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Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01436305
Recruitment Status : Terminated (Secondary to safety concerns plus change in Campath® (alemtuzumab) availability.)
First Posted : September 19, 2011
Results First Posted : August 30, 2017
Last Update Posted : September 27, 2017
Sponsor:
Collaborator:
Clinical Trials in Organ Transplantation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Kidney Transplantation
Renal Transplantation
Interventions Drug: Alemtuzumab
Drug: MMF
Biological: Basiliximab
Drug: Short-term Tac
Drug: tacrolimus
Biological: Belatacept
Drug: methylprednisolone
Enrollment 19
Recruitment Details Three sites in the United States enrolled a total of 19 participants in the study.
Pre-assignment Details  
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Period Title: Overall Study
Started 6 6 7
Completed 4 2 7
Not Completed 2 4 0
Reason Not Completed
Death             1             0             0
Lost to Follow-up             0             1             0
Withdrawal by Subject             1             3             0
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac Total
Hide Arm/Group Description

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Total of all reporting groups
Overall Number of Baseline Participants 6 6 7 19
Hide Baseline Analysis Population Description
Randomized participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 7 participants 19 participants
46.8  (13.1) 43.3  (9.5) 49.1  (9.0) 46.6  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 7 participants 19 participants
Female
2
  33.3%
3
  50.0%
1
  14.3%
6
  31.6%
Male
4
  66.7%
3
  50.0%
6
  85.7%
13
  68.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 7 participants 19 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
6
 100.0%
6
 100.0%
4
  57.1%
16
  84.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
3
  42.9%
3
  15.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 7 participants 19 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  16.7%
0
   0.0%
1
   5.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  33.3%
1
  16.7%
5
  71.4%
8
  42.1%
White
4
  66.7%
4
  66.7%
2
  28.6%
10
  52.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 7 participants 19 participants
6 6 7 19
1.Primary Outcome
Title Mean Glomerular Filtration Rate (GFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52
Hide Description GFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI). A score of ≥ 90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with measurable data at Week 52
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 4 3 7
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73m^2
55.9  (8.9) 51.6  (23.5) 58.3  (12.2)
2.Secondary Outcome
Title Count of Participants With Biopsy Proven Acute Rejection at Any Time Post-Transplant
Hide Description Biopsy proven acute rejection was defined as histologic evidence of borderline or higher cellular rejection per local pathologist.
Time Frame Transplantation through last study visit (up to week 156)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 6 6 7
Measure Type: Count of Participants
Unit of Measure: Participants
3
  50.0%
2
  33.3%
5
  71.4%
3.Secondary Outcome
Title Count of Participants With Estimated Glomerular Filtration Rate (GFR) < 60 mL/Min/1.73 m^2 by CKD EPI
Hide Description GFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI). A score of ≥90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure. This measure specifically looked at participants with scores less than 60.
Time Frame Week 52, Week 104, and Week 156
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data at Weeks 52, 104 and 156.
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 4 3 7
Measure Type: Count of Participants
Unit of Measure: Participants
Week 52 Number Analyzed 4 participants 3 participants 7 participants
3
  75.0%
2
  66.7%
4
  57.1%
Week 104 Number Analyzed 3 participants 2 participants 7 participants
2
  66.7%
1
  50.0%
3
  42.9%
Week 156 Number Analyzed 3 participants 2 participants 7 participants
2
  66.7%
1
  50.0%
2
  28.6%
4.Secondary Outcome
Title Count of Participants by Chronic Kidney Disease (CKD) Stage Post-Transplant
Hide Description

The stages of Chronic Kidney Disease are defined using the participant's GFR value as indicated below:

Stage 1 if GFR value is ≥90; Stage 2 if GFR value is ≥60 and < 90; Stage 3A if 45 ≤GFR < 60; Stage 3B if 30 ≤ GFR < 45; Stage 4 if 15 ≤GFR < 30;l Stage 5 if GFR < 15.

Stage 1 means kidney function is normal. Stage 2 indicates mildly reduced kidney function, pointing to kidney disease. Stages 3A and 3B indicate moderately reduced kidney function. Stage 4 indicates severely reduced kidney function. Stage 5 indicates very severe or end stage kidney failure.

Time Frame Week 52, Week 104, and Week 156
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data at Weeks 52, 104 and 156
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 4 3 7
Measure Type: Count of Participants
Unit of Measure: Participants
Week 52 - Stage 1 Number Analyzed 4 participants 3 participants 7 participants
0
   0.0%
0
   0.0%
0
   0.0%
Week 52 - Stage 2 Number Analyzed 4 participants 3 participants 7 participants
1
  25.0%
1
  33.3%
3
  42.9%
Week 52 - Stage 3A Number Analyzed 4 participants 3 participants 7 participants
3
  75.0%
1
  33.3%
3
  42.9%
Week 52 - Stage 3B Number Analyzed 4 participants 3 participants 7 participants
0
   0.0%
0
   0.0%
1
  14.3%
Week 52 - Stage 4 Number Analyzed 4 participants 3 participants 7 participants
0
   0.0%
1
  33.3%
0
   0.0%
Week 104 - Stage 1 Number Analyzed 3 participants 2 participants 7 participants
0
   0.0%
1
  50.0%
1
  14.3%
Week 104 - Stage 2 Number Analyzed 3 participants 2 participants 7 participants
1
  33.3%
0
   0.0%
3
  42.9%
Week 104 - Stage 3A Number Analyzed 3 participants 2 participants 7 participants
1
  33.3%
1
  50.0%
2
  28.6%
Week 104 - Stage 3B Number Analyzed 3 participants 2 participants 7 participants
1
  33.3%
0
   0.0%
1
  14.3%
Week 104 - Stage 4 Number Analyzed 3 participants 2 participants 7 participants
0
   0.0%
0
   0.0%
0
   0.0%
Week 156 - Stage 1 Number Analyzed 3 participants 2 participants 7 participants
0
   0.0%
0
   0.0%
0
   0.0%
Week 156 - Stage 2 Number Analyzed 3 participants 2 participants 7 participants
1
  33.3%
1
  50.0%
5
  71.4%
Week 156 - Stage 3A Number Analyzed 3 participants 2 participants 7 participants
1
  33.3%
1
  50.0%
1
  14.3%
Week 156 - Stage 3B Number Analyzed 3 participants 2 participants 7 participants
1
  33.3%
0
   0.0%
1
  14.3%
Week 156 - Stage 4 Number Analyzed 3 participants 2 participants 7 participants
0
   0.0%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Count of Participants With CKD Stage 4 or 5
Hide Description

The stages of Chronic Kidney Disease are defined using the participant's GFR value as indicated below.

Stage 1 if GFR value is ≥90; Stage 2 if 60 ≤ GFR < 90; Stage 3A if 45 ≤ GFR < 60; Stage 3B if 30 ≤ GFR < 45; Stage 4 if 15 ≤ GFR < 30; Stage 5 if GFR < 15.

Stage 1 means kidney function is normal. Stage 2 indicates mildly reduced kidney function, pointing to kidney disease. Stages 3A abd 3B indicate moderately reduced kidney function. Stage 4 indicates severely reduced kidney function. Stage 5 indicates very severe or end stage kidney failure.

Time Frame Week 52, Week 104, and Week 156
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data at Weeks 52, 104 and 156
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 4 3 7
Measure Type: Count of Participants
Unit of Measure: Participants
Week 52 Number Analyzed 4 participants 3 participants 7 participants
0
   0.0%
1
  33.3%
0
   0.0%
Week 104 Number Analyzed 3 participants 2 participants 7 participants
0
   0.0%
0
   0.0%
0
   0.0%
Week 156 Number Analyzed 3 participants 2 participants 7 participants
0
   0.0%
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Mean Calculated eGFR Using MDRD 4 Variable Model
Hide Description The estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease equation (MDRD). A score of ≥90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure.
Time Frame Week 52, Week 104, and Week 156
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data at Weeks 52, 104 and 156
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 4 3 7
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73m^2
Week 52 Number Analyzed 4 participants 3 participants 7 participants
52.4  (8.3) 47.8  (22.3) 55.7  (11.0)
Week 104 Number Analyzed 3 participants 2 participants 7 participants
54.2  (13.1) 69.3  (27.3) 60.4  (16.8)
Week 156 Number Analyzed 3 participants 2 participants 7 participants
49.0  (16.3) 65.5  (20.2) 61.5  (13.9)
7.Secondary Outcome
Title The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine
Hide Description The estimated Glomerular Filtration Rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation (CKD-EPI). A score of ≥90 means kidney function is normal. A score between 60 and 89 indicates mildly reduced kidney function, pointing to kidney disease. Scores between 30 and 59 indicates moderately reduced kidney function. Scores between 15 and 29 indicate severely reduced kidney function. Scores below 15 indicate very severe or endstage kidney failure. An estimate of the slope, or change over time, in eGFR was produced using standard statistical linear modeling procedures. The estimate was then re-scaled so that it can be interpreted as a change in eGFR per month. Positive numbers indicate increasing kidney function. Larger numbers indicate greater change in kidney function.
Time Frame Week 52, Week 104, and Week 156
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat with available data
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 6 4 7
Mean (Standard Deviation)
Unit of Measure: Change in eGFR (mL/min/1.73m^2) by month
Week 52 1.29  (1.85) 0.62  (0.99) 1.07  (1.16)
Week 104 1.27  (1.86) 0.62  (1.18) 0.68  (0.83)
Week 156 1.33  (1.82) 0.69  (1.14) 0.48  (0.48)
8.Secondary Outcome
Title Count of Participants With Delayed Graft Function Post-Transplant
Hide Description Delayed graft function is defined as dialysis in the first week on one or more occasions for any indication other than the treatment of acute hyperkalemia in the setting of otherwise acceptable renal function
Time Frame Any time within the first week post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 6 6 7
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
  33.3%
0
   0.0%
9.Secondary Outcome
Title An Increase of One or More Grades of CAN/IFTA When Comparing the Implantation and Subsequent Protocol Biopsies
Hide Description CAN/IFTA grades reflect the severity of interstitial fibrosis and tubular atrophy present in the tissue obtained during a kidney biopsy. Higher grades indicate greater severity in interstitial fibrosis and tubular atrophy present the kidney biopsy tissue. The aim of this measure was to compare central lab reviewed pre-implantation biopsies to post-transplant biopsies, as pre-specified per protocol; however, the central lab had an inadequate set of biopsies to proceed with evaluation.
Time Frame Week 52, Week 104, and Week 156
Hide Outcome Measure Data
Hide Analysis Population Description
There was an insufficient number of biopsies collected for the summarized data to be reliable.
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Count of Participants With CAN/IFTA Grade I, II or III at Any Time Post-transplant
Hide Description CAN/IFTA grades were determined per local pathology interpretations of biopsy tissue. These grades reflect the severity of interstitial fibrosis and tubular atrophy present in the tissue obtained during a kidney biopsy. Higher grades indicate greater severity in interstitial fibrosis and tubular atrophy present the kidney biopsy tissue.
Time Frame Transplantation through last study visit (up to week 156)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 6 6 7
Measure Type: Count of Participants
Unit of Measure: Participants
1
  16.7%
3
  50.0%
5
  71.4%
11.Secondary Outcome
Title Count of Participants With Acute Cellular Rejection Grade Equal to or Greater Than IA, by the Banff 2007 Criteria
Hide Description Acute cellular rejection is when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade ≥ IA by Banff 2007 criteria.
Time Frame Transplantation through last study visit (up to week 156)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 6 6 7
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2
  33.3%
4
  57.1%
12.Secondary Outcome
Title Count of Participants by Severity of First Acute Cellular Rejection by Wk 52
Hide Description Acute cellular rejection is when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade ≥ IA by Banff 2007 criteria. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection. Originally, this endpoint was worded as "The severity of first and highest acute cellular rejection within the first 52 weeks." But since the highest grade for each subject coincided with the first ACR episode for each subject, only a summary of severity of the first episode is presented here.
Time Frame Transplantation through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 6 6 7
Measure Type: Count of Participants
Unit of Measure: Participants
Grade IA
0
   0.0%
1
  16.7%
1
  14.3%
Grade IB
0
   0.0%
0
   0.0%
0
   0.0%
Grade IIA
0
   0.0%
0
   0.0%
2
  28.6%
Grade IIB
0
   0.0%
1
  16.7%
1
  14.3%
Grade III
0
   0.0%
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Count of Participants With Antibody Mediated Rejection
Hide Description Antibody mediated rejection (AMR) is defined as diffusely positive staining for C4d, presence of circulating anti-donor antibodies and morphologic evidence of acute tissue injury.
Time Frame Transplantation through last study visit (up to week 156)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 6 6 7
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
  16.7%
0
   0.0%
14.Secondary Outcome
Title Type of Treatment of Rejection
Hide Description

Upon having a biopsy performed, persons often receive treatment for rejection based on the results of the biopsy, which may or may not have shown signs of rejection. Details of biopsy findings and corresponding treatment are presented here for each instance of treatment for rejection. Acronyms and abbreviations are defined below.

ACR=Acute Cellular Rejection ATG=Anti-thymocyte globulin therapy Chr. AMR=Chronic Antibody Mediated Rejection Gd.=Grade IFTA=Interstitial Fibrosis and Tubular Atrophy IVIG=Intravenous Immunoglobulin therapy.

Only 'for cause' biopsies were performed post-transplant; thus, it is possible for a participant to be included in the analysis population and not have a biopsy for this outcome measure.

Time Frame Transplantation through last study visit (up to week 156)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 6 6 7
Overall Number of Units Analyzed
Type of Units Analyzed: Biopsies
5 10 10
Measure Type: Number
Unit of Measure: Biopsy
Borderline rejection; IVIG and plasmapheresis 1 0 0
ACR Gd. IA + Chr. AMR + IFTA Gd. I; Pulse Steroids 0 1 0
ACR Gd. IA + IFTA Gd. II; Pulse Steroids 0 1 0
ACR Gd. IIB; ATG and Pulse Steroids 0 1 0
Borderline + IFTA Gd. I; with Pulse Steroids 0 0 1
ACR Gd. IA + IFTA Gd. I; Pulse Steroids 0 0 1
ACR Gd. IIA; Pulse Steroids 0 0 1
ACR Gd. IIA + IFTA Gd. I; ATG and Pulse Steroids 0 0 2
ACR Gd. IIB + IFTA Gd. I; ATG and Pulse Steroids 0 0 1
15.Secondary Outcome
Title Count of Participants With de Novo Anti-donor HLA Antibodies at Wk 52
Hide Description The presence of antibodies reactive to Histocompatibility Antigen (HLA) molecules expressed on the renal allograft have been associated with both acute and chronic injury to the transplanted kidney. The development of de novo anti- donor HLA antibodies may mean a person is more likely to reject the graft.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 6 6 7
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
16.Secondary Outcome
Title Count of Participants With Either New Onset Diabetes After Transplant (NODAT) or Impaired Fasting Glucose (IFG) at Wk 52 Based on Criteria Specified by the ADA and WHO
Hide Description

New onset diabetes is the development of diabetes post-kidney transplant. It was identified by the clinical sites caring for each participant and reported directly in the clinical database. Impaired fasting glucose (IFG) is a determination made by referencing glucose measurements obtained from a standard chemistry panel. Any fasting glucose measure that is between 110 and 125 mg/dL is classified as IFG.

Acronyms: American Diabetes Association (ADA); World Health Organization (WHO).

Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 6 6 7
Measure Type: Count of Participants
Unit of Measure: Participants
New onset diabetes during first 52 weeks Number Analyzed 6 participants 6 participants 7 participants
0
   0.0%
0
   0.0%
0
   0.0%
Impaired fasting glucose at week 52 Number Analyzed 4 participants 2 participants 6 participants
1
  25.0%
0
   0.0%
0
   0.0%
17.Secondary Outcome
Title Count of Participants With Treated Diabetes Between Day 14 and Wk 52
Hide Description Treated diabetes is defined as the receipt of oral medication or insulin for >14 days between 14 days and 52 weeks post-transplant
Time Frame Day 14 to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat with available data
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 4 3 7
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
0
   0.0%
1
  14.3%
18.Secondary Outcome
Title HbA1c Measured at Days 28 & 84, and Weeks 24, 36, 52, 72, 104 and 156
Hide Description Hemoglobin A1c (HbA1c) measures the average blood glucose levels over 8-12 weeks, thus acting as a useful long-term gauge of blood glucose control. A value below 6.0% reflects normal levels, 6.0% to 6.4% reflects prediabetes, and a value of ≥ 6.5% reflects diabetes.
Time Frame Day 28, Day 84, Week 24, Week 36, Week 52, Week 72, Week 104, Week 156
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat with available data
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 6 4 7
Mean (Standard Deviation)
Unit of Measure: percent
Day 28 Number Analyzed 6 participants 4 participants 6 participants
5.3  (1.1) 5.1  (0.5) 5.8  (0.2)
Day 84 Number Analyzed 5 participants 4 participants 7 participants
5.7  (1.4) 5.0  (0.6) 5.9  (0.8)
Week 24 Number Analyzed 4 participants 3 participants 6 participants
6.9  (1.8) 5.1  (0.3) 6.5  (1.0)
Week 36 Number Analyzed 2 participants 2 participants 4 participants
6.7  (1.5) 5.3  (0.4) 7.2  (2.6)
Week 52 Number Analyzed 3 participants 2 participants 1 participants
7.0  (2.9) 4.8  (0.7) 7.6
Week 72 Number Analyzed 0 participants 0 participants 1 participants
8.1
Week 104 Number Analyzed 2 participants 2 participants 5 participants
5.7  (0.4) 5.2  (0.1) 6.6  (1.8)
Week 156 Number Analyzed 2 participants 2 participants 6 participants
5.6  (0.1) 5.2  (0.1) 7.8  (2.5)
19.Secondary Outcome
Title Standardized Blood Pressure Measurement at Wk 52
Hide Description A blood pressure measurement consists of two numbers: the systolic and diastolic pressures. Systolic pressure measures the pressure in blood vessels when the heart beats. Diastolic pressure measures the pressure in blood vessels between beats of the heart. Systolic measures of <120 and diastolic measures of <80 are considered normal. Systolic measures of 120-139 and diastolic measures of 80-89 are considered at risk (or pre-hypertension). Systolic measures of ≥140 and diastolic measures of ≥90 are considered high.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat with available data at Week 52
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 4 3 7
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic Blood Pressure at Week 52 147.5  (18.7) 146.7  (5.1) 139.9  (18.1)
Diastolic Blood Pressure at Week 52 80.8  (12.8) 92.7  (9.8) 79.3  (8.5)
20.Secondary Outcome
Title Count of Participants With Use of Anti-hypertensive Medications at Wk 52
Hide Description Anti-hypertensive medications are a class of drugs that are used to treat hypertension. The medications seek to prevent the complications of high blood pressure, such as stoke and myocardial infarction.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat with available data at Week 52
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 4 3 7
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
3
 100.0%
7
 100.0%
21.Secondary Outcome
Title Fasting Lipid Profile (Total Cholesterol, Non-HDL Cholesterol, LDL, HDL, and Triglyceride) at Baseline and Wks 24, 52, 104 and 156
Hide Description

A fasting lipid profiles measures total cholesterol, LDL cholesterol, HDL cholesterol, and triglyceride levels. These measurements are used in assessing one's risk of cardiovascular disease. Target ranges for each of these measures are detailed below.

Total cholesterol: 75-169 mg/dL if age ≤ 20; 100-199 mg/dL if age ≥ 21; high values indicate risk of cardiovascular disease

LDL cholesterol: <70 mg/dL for people with documented cardiovascular disease or metabolic syndrome; <100 mg/dL for people considered high risk for cardiovascular disease; <130 mg/dL for people considered low risk for cardiovascular disease; high values indicate risk of cardiovascular disease

HDL cholesterol: 40mg/dL and higher; high values indicate reduced risk of cardiovascular disease

Non-HDL cholesterol: 30 mg/dL above the target value for LDL cholesterol; high values indicate risk of cardiovascular disease

Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease

Time Frame Baseline, Week 24, Week 52, Week 104, Week 156
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 6 6 7
Mean (Standard Deviation)
Unit of Measure: mg/dL
Tot. Chol. Baseline Number Analyzed 6 participants 6 participants 7 participants
141.2  (28.8) 160.2  (37.8) 165.6  (37.4)
Tot. Chol. W24 Number Analyzed 5 participants 3 participants 7 participants
171.6  (44.0) 159.0  (11.1) 185.6  (40.1)
Tot. Chol. W52 Number Analyzed 4 participants 1 participants 2 participants
156.0  (30.7) 187.0 157.5  (53.0)
Tot. Chol. W104 Number Analyzed 2 participants 2 participants 5 participants
170.5  (2.1) 142.5  (3.5) 189.0  (49.9)
Tot. Chol. W156 Number Analyzed 2 participants 2 participants 6 participants
183.5  (3.5) 133.5  (7.8) 181.7  (60.6)
Non-HDL Baseline Number Analyzed 6 participants 6 participants 7 participants
108.2  (22.0) 118.8  (19.0) 122.3  (44.9)
Non-HDL W24 Number Analyzed 5 participants 3 participants 7 participants
128.0  (38.0) 129.3  (10.0) 129.0  (35.3)
Non-HDL W52 Number Analyzed 4 participants 1 participants 1 participants
117.5  (23.4) 151.0 61.0
Non-HDL W104 Number Analyzed 2 participants 2 participants 5 participants
129.5  (0.7) 110.5  (3.5) 135.6  (42.4)
Non-HDL W156 Number Analyzed 2 participants 2 participants 6 participants
138.5  (2.1) 102.5  (2.1) 136.0  (58.0)
LDL Baseline Number Analyzed 6 participants 6 participants 7 participants
76.7  (22.0) 86.6  (29.8) 83.4  (41.4)
LDL W24 Number Analyzed 5 participants 3 participants 7 participants
76.7  (22.0) 86.6  (29.8) 83.4  (41.4)
LDL W52 Number Analyzed 4 participants 1 participants 1 participants
69.5  (38.0) 114.0 49.0
LDL W104 Number Analyzed 2 participants 2 participants 5 participants
100.5  (0.7) 58.0  (18.4) 101.4  (42.3)
LDL W156 Number Analyzed 2 participants 2 participants 6 participants
116.0  (2.8) 55.5  (19.1) 106.0  (46.3)
HDL Baseline Number Analyzed 6 participants 6 participants 7 participants
33.0  (10.4) 41.3  (22.8) 43.3  (10.7)
HDL W24 Number Analyzed 5 participants 3 participants 7 participants
43.6  (8.2) 29.7  (2.1) 56.6  (19.6)
HDL W52 Number Analyzed 4 participants 1 participants 1 participants
38.5  (12.3) 36.0 59.0
HDL W104 Number Analyzed 2 participants 2 participants 5 participants
41.0  (2.8) 32.0  (7.1) 53.4  (16.6)
HDL W156 Number Analyzed 2 participants 2 participants 6 participants
45.0  (1.4) 31.0  (5.7) 45.7  (14.6)
Triglyc. Baseline Number Analyzed 6 participants 6 participants 7 participants
158.7  (92.4) 307.8  (350.1) 206.9  (148.5)
Triglyc. W24 Number Analyzed 5 participants 3 participants 7 participants
161.0  (53.9) 249.7  (172.4) 115.9  (68.1)
Triglyc. W52 Number Analyzed 4 participants 1 participants 1 participants
319.3  (294.0) 187.0 58.0
Triglyc. W104 Number Analyzed 2 participants 2 participants 5 participants
146.0  (1.4) 220.0  (168.3) 172.8  (130.0)
Triglyc. W156 Number Analyzed 2 participants 2 participants 6 participants
115.0  (4.2) 228.0  (93.3) 156.5  (75.6)
22.Secondary Outcome
Title Count of Participants With Use of Lipid Lowering Medications at Baseline and Wks 24, 52, 104 and 156
Hide Description Lipid lowering medications are used in the treatment of high levels of fats (lipids), such as cholesterol in blood
Time Frame Baseline, Week 24, Week 52, Week 104, Week 156
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 6 6 7
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 6 participants 6 participants 7 participants
5
  83.3%
1
  16.7%
2
  28.6%
Week 24 Number Analyzed 6 participants 4 participants 7 participants
4
  66.7%
1
  25.0%
2
  28.6%
Week 52 Number Analyzed 4 participants 3 participants 7 participants
3
  75.0%
1
  33.3%
2
  28.6%
Week 104 Number Analyzed 4 participants 3 participants 7 participants
3
  75.0%
1
  33.3%
3
  42.9%
Week 156 Number Analyzed 4 participants 2 participants 7 participants
3
  75.0%
1
  50.0%
3
  42.9%
23.Secondary Outcome
Title Total Daily Prescribed Pill Number at Days 28 and 84, and Wks 24, 36, 52, 72, 104 and 156
Hide Description This is a measure of the total number of pills a participant was prescribed on a given day
Time Frame Day 28, Day 84, Week 24, Week 36, Week 52, Week 72, Week 104, Week 156
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat with available data
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 6 4 7
Mean (Standard Deviation)
Unit of Measure: Number of pills
Day 28 Number Analyzed 6 participants 4 participants 7 participants
28.8  (12.3) 15.8  (6.3) 27.3  (7.6)
Day 84 Number Analyzed 6 participants 4 participants 7 participants
22.2  (6.6) 13.5  (4.4) 21.3  (7.5)
Week 24 Number Analyzed 5 participants 3 participants 7 participants
14.8  (3.8) 8.3  (4.0) 16.6  (5.7)
Week 36 Number Analyzed 3 participants 3 participants 7 participants
13.0  (2.0) 14.0  (1.0) 17.0  (5.1)
Week 52 Number Analyzed 4 participants 3 participants 6 participants
14.6  (5.0) 14.3  (1.5) 17.8  (3.5)
Week 72 Number Analyzed 0 participants 0 participants 4 participants
16.0  (4.4)
Week 104 Number Analyzed 4 participants 2 participants 6 participants
15.3  (5.7) 15.5  (2.1) 14.8  (5.3)
Week 156 Number Analyzed 4 participants 2 participants 7 participants
14.0  (6.2) 15.0  (1.4) 12.7  (6.2)
24.Secondary Outcome
Title Number of Events of Death or Graft Loss
Hide Description This measure counts deaths and graft loss occurring at any point post transplantation. Graft loss is defined as need for dialysis for greater than 30 days duration, allograft nephrectomy, or retransplantation.
Time Frame Transplantation through last study visit (up to week 156)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 6 6 7
Measure Type: Number
Unit of Measure: Events
2 3 0
25.Secondary Outcome
Title Count of Participants With Rejection
Hide Description The number of participants who were treated by their local physician for any type of rejection including, but not limited to cellular rejection and antibody- mediated rejection of the transplanted kidney regardless of the presence of a biopsy.
Time Frame Transplantation through last study visit (up to week 156)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 6 6 7
Measure Type: Count of Participants
Unit of Measure: Participants
1
  16.7%
3
  50.0%
5
  71.4%
26.Secondary Outcome
Title Number of All Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description Adverse events were collected systematically from enrollment through last study visit. Displayed below are counts of all adverse events per treatment group (including both serious and non-serious adverse events). Separately counts of all adverse events determined to be serious are displayed per treatment group. More detail about adverse events for this trial is displayed in the 'Adverse Event' section.
Time Frame Enrollment through last study visit (up to week 156)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 6 6 7
Measure Type: Number
Unit of Measure: Events
All Adverse Events 21 25 40
Serious Adverse Events 6 11 7
27.Secondary Outcome
Title Count of Participants With Infections Requiring Hospitalization or Systemic Therapy Reported as Serious Adverse Events
Hide Description Infections of certain types (i.e., excluding those identified in the protocol as occurring commonly in this study population) were required to be reported as a serious adverse event if they required either inpatient hospitalization of prolongation of a current hospitalization.
Time Frame Transplantation through last study visit (up to week 156)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 6 6 7
Measure Type: Count of Participants
Unit of Measure: Participants
2
  33.3%
2
  33.3%
1
  14.3%
28.Secondary Outcome
Title Count of Participants With BKV and CMV Viremia (Local Center Monitoring) Reported as Adverse Events
Hide Description

Viral infections following renal transplantation is significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during this study using participant blood samples.

Acronyms: BK Polyoma Virus (BKV); Cytomegalovirus (CMV).

Time Frame Transplantation through last study visit (up to week 156)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 6 6 7
Measure Type: Count of Participants
Unit of Measure: Participants
BKV
0
   0.0%
0
   0.0%
2
  28.6%
CMV
1
  16.7%
0
   0.0%
0
   0.0%
29.Secondary Outcome
Title Count of Participants With EBV Infection as Reported on the Case Report Form as Adverse Events
Hide Description

Viral infections following renal transplantation is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during this study using participant blood samples.

Acronym: Epstein-Barr virus (EBV)

Time Frame Transplantation through last study visit (up to week 156)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 6 6 7
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
30.Secondary Outcome
Title Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90mm Hg Within 24 Hours of Onset of Transplant Procedure
Hide Description Temperature of >39 degrees Celsius would be an indication of fever most often in response to an infection or illness. Systolic blood pressure <90mm Hg would be an indication of low blood pressure.
Time Frame 24 hours after transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description:

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

Overall Number of Participants Analyzed 6 6 7
Measure Type: Count of Participants
Unit of Measure: Participants
Fever >39 degrees
0
   0.0%
0
   0.0%
0
   0.0%
Systolic BP <90
0
   0.0%
1
  16.7%
0
   0.0%
Time Frame Enrollment through study completion, up to 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Hide Arm/Group Description

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter.

Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation.

Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy.

Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day.

Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant.

Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks.

Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped.

All-Cause Mortality
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)      0/6 (0.00%)      0/7 (0.00%)    
Hide Serious Adverse Events
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/6 (50.00%)      5/6 (83.33%)      5/7 (71.43%)    
Blood and lymphatic system disorders       
Leukopenia  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0
Gastrointestinal disorders       
Gastrooesophageal reflux disease  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0
General disorders       
Pyrexia  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0
Suprapubic pain  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0
Hepatobiliary disorders       
Cholelithiasis  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0
Immune system disorders       
Transplant rejection  1  0/6 (0.00%)  0 1/6 (16.67%)  1 3/7 (42.86%)  3
Infections and infestations       
Arteriovenous graft site infection  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1
Cytomegalovirus infection  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0
Endocarditis staphylococcal  1  1/6 (16.67%)  2 0/6 (0.00%)  0 0/7 (0.00%)  0
Infected skin ulcer  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0
Urinary tract infection  1  1/6 (16.67%)  1 1/6 (16.67%)  1 0/7 (0.00%)  0
Investigations       
Blood creatinine increased  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Basal cell carcinoma  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0
Renal and urinary disorders       
Renal failure acute  1  0/6 (0.00%)  0 0/6 (0.00%)  0 2/7 (28.57%)  2
Renal vein thrombosis  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0
Vascular disorders       
Arterial thrombosis  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0
Peripheral artery dissection  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0
Venous thrombosis  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0
1
Term from vocabulary, MedDRA 14.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus Induction: Alemtuzumab, Maintenance: MMF + Belatacept Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      4/6 (66.67%)      7/7 (100.00%)    
Blood and lymphatic system disorders       
Iron deficiency anaemia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1
Leukopenia  1  1/6 (16.67%)  1 1/6 (16.67%)  1 1/7 (14.29%)  5
Cardiac disorders       
Tachycardia  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0
Eye disorders       
Asthenopia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1
Gastrointestinal disorders       
Diarrhoea  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1
Nausea  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1
Immune system disorders       
Transplant rejection  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0
Type IV hypersensitivity reaction  1  0/6 (0.00%)  0 1/6 (16.67%)  1 2/7 (28.57%)  2
Infections and infestations       
Acarodermatitis  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1
Gastroenteritis  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0
Urinary tract infection  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  4
Urinary tract infection bacterial  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0
Injury, poisoning and procedural complications       
Complications of transplanted kidney  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0
Perirenal haematoma  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0
Investigations       
Blood creatinine increased  1  2/6 (33.33%)  2 0/6 (0.00%)  0 2/7 (28.57%)  5
Blood urea increased  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0
Haematocrit increased  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0
Haemoglobin increased  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0
Liver function test abnormal  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1
Polyomavirus test positive  1  0/6 (0.00%)  0 0/6 (0.00%)  0 2/7 (28.57%)  2
White blood cell count decreased  1  1/6 (16.67%)  1 1/6 (16.67%)  2 0/7 (0.00%)  0
Metabolism and nutrition disorders       
Hypercalcaemia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  2
Hyperkalaemia  1  0/6 (0.00%)  0 1/6 (16.67%)  1 1/7 (14.29%)  1
Hypoglycaemia  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lipoma  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1
Nervous system disorders       
Migraine  1  0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0
Syncope  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0
Tremor  1  2/6 (33.33%)  2 1/6 (16.67%)  1 0/7 (0.00%)  0
Renal and urinary disorders       
Proteinuria  1  1/6 (16.67%)  2 0/6 (0.00%)  0 0/7 (0.00%)  0
Renal artery thrombosis  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0
Skin and subcutaneous tissue disorders       
Hyperhidrosis  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1
Night sweats  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1
Rash  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1
Urticaria  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/7 (0.00%)  0
Vascular disorders       
Haematoma  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1
Hypotension  1  0/6 (0.00%)  0 2/6 (33.33%)  2 0/7 (0.00%)  0
1
Term from vocabulary, MedDRA 14.1
Indicates events were collected by systematic assessment
Enrollment of 210 participants was planned, but study was stopped after 19 participants enrolled due to safety concerns and change in alemtuzumab availability. Enrolled participants continued follow-up after enrollment ended.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Clinical Research Operations Program
Organization: DAIT/NIAID
Phone: 301-594-7669
EMail: DAITClinicalTrialsGov@niaid.nih.gov
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01436305    
Other Study ID Numbers: DAIT CTOT-10
First Submitted: September 13, 2011
First Posted: September 19, 2011
Results First Submitted: November 10, 2016
Results First Posted: August 30, 2017
Last Update Posted: September 27, 2017