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Open-Label Phase 2 Trial of a Steroid-Free, CNI-Free, Belatacept-Based Immunosuppressive Regimen

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: NCT01856257
Recruitment Status : Terminated (Safety: Stopping rule not met.)
First Posted : May 17, 2013
Results First Posted : August 7, 2017
Last Update Posted : December 17, 2020
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 Primary Renal Allograft Candidate
Kidney Transplantation
Interventions Biological: Anti-thymocyte Globulin (Rabbit)
Biological: belatacept
Drug: methylprednisolone
Biological: basiliximab
Drug: mycophenolate mofetil
Drug: tacrolimus
Enrollment 71
Recruitment Details Three sites in the United States recruited and enrolled 71 participants into this trial.
Pre-assignment Details  
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept Enrolled, Not Randomized
Hide Arm/Group Description

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
Period Title: Overall Study
Started 29 29 11 2
Completed 26 28 11 0
Not Completed 3 1 0 2
Reason Not Completed
Death             2             0             0             0
Physician Decision             0             0             0             1
Withdrawal by Subject             1             1             0             0
Donor complication             0             0             0             1
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept Total
Hide Arm/Group Description

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Total of all reporting groups
Overall Number of Baseline Participants 29 29 11 69
Hide Baseline Analysis Population Description
Randomized Participants
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 11 participants 69 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
29
 100.0%
29
 100.0%
11
 100.0%
69
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 29 participants 11 participants 69 participants
47.7  (6.76) 44.5  (10.45) 44.6  (9.63) 45.9  (8.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 11 participants 69 participants
Female
9
  31.0%
8
  27.6%
4
  36.4%
21
  30.4%
Male
20
  69.0%
21
  72.4%
7
  63.6%
48
  69.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 11 participants 69 participants
Hispanic or Latino
2
   6.9%
2
   6.9%
1
   9.1%
5
   7.2%
Not Hispanic or Latino
26
  89.7%
25
  86.2%
9
  81.8%
60
  87.0%
Unknown or Not Reported
1
   3.4%
2
   6.9%
1
   9.1%
4
   5.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 11 participants 69 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   3.4%
3
  10.3%
0
   0.0%
4
   5.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
16
  55.2%
13
  44.8%
5
  45.5%
34
  49.3%
White
9
  31.0%
11
  37.9%
4
  36.4%
24
  34.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
  10.3%
2
   6.9%
2
  18.2%
7
  10.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 29 participants 11 participants 69 participants
29 29 11 69
1.Primary Outcome
Title Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant
Hide Description

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 end stage kidney failure.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data at week 52
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 26 27 11
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73m^2
59.2  (19.9) 61.5  (23.3) 63.0  (17.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac, Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.544
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.512
Confidence Interval (2-Sided) 95%
-7.999 to 15.024
Estimation Comments The p-value, estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from weeks 4, 12, 28, 36, and 52 to compare Group 2 to Group 1.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac, Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.531
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.820
Confidence Interval (2-Sided) 95%
-10.481 to 20.121
Estimation Comments P-value estimate of the treatment group difference, and estimated 95% confidence interval result from a repeated measures mixed model using available eGFR data from weeks 4, 12, 28, 36, and 52 to compare Group 3 to Group 1.
2.Secondary Outcome
Title Count of Participants With Biopsy Proven Acute Rejection By Wk 52 Post-Transplant
Hide Description Biopsy proven acute rejection definition: histologic evidence of a Banff grade of ≥1A per local pathologist.
Time Frame Transplantation through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 29 29 11
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.4%
10
  34.5%
4
  36.4%
3.Secondary Outcome
Title Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant
Hide Description

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 end stage kidney failure.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 29 29 11
Measure Type: Count of Participants
Unit of Measure: Participants
21
  72.4%
15
  51.7%
6
  54.5%
4.Secondary Outcome
Title Count of Participants by CKD Stage at Wk 52
Hide Description

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

  • Stage 1 if GFR value is ≥90 ( kidney function is normal)
  • Stage 2 if 60 ≤ GFR < 90 (mildly reduced kidney function, pointing to kidney disease)
  • Stage 3A if 45 ≤ GFR < 60*
  • Stage 3B if 30 ≤ GFR < 45*
  • Stage 4 if 15 ≤ GFR < 30 (severely reduced kidney function)
  • Stage 5 if GFR < 15 (severe or end stage kidney failure).

Stages 3A and 3B indicate moderately reduced kidney function.*

Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 29 29 11
Measure Type: Count of Participants
Unit of Measure: Participants
Stage 1
3
  10.3%
3
  10.3%
1
   9.1%
Stage 2
5
  17.2%
11
  37.9%
4
  36.4%
Stage 3A
11
  37.9%
9
  31.0%
6
  54.5%
Stage 3B
6
  20.7%
2
   6.9%
0
   0.0%
Stage 4
1
   3.4%
1
   3.4%
0
   0.0%
Stage 5
3
  10.3%
3
  10.3%
0
   0.0%
5.Secondary Outcome
Title Count of Participants With Defined CKD Stage 4 or 5 at Wk 52 Post-Transplant
Hide Description

The stages of Chronic Kidney Disease (CKD) are defined using the participant's GFR value:

  • Stage 1 if GFR value is ≥ 90 (kidney function is normal)
  • Stage 2 if 60 ≤ GFR < 90 (mildly reduced kidney function, pointing to kidney disease)
  • Stage 3A if 45 <= GFR < 60*
  • Stage 3B if 30 <= GFR < 45*
  • Stage 4 if 15 ≤ GFR < 30 (severely reduced kidney function)
  • Stage 5 if GFR < 15 (severe or end stage kidney failure).

Stages 3A abd 3B indicate moderately reduced kidney function.*

Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 29 29 11
Measure Type: Count of Participants
Unit of Measure: Participants
4
  13.8%
4
  13.8%
0
   0.0%
6.Secondary Outcome
Title Mean Calculated eGFR Using MDRD 4 Variable Model at Wk 52 Post-Transplant
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 severe or endstage kidney failure.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 26 27 11
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73m^2
56.1  (18.5) 57.0  (20.7) 58.2  (14.4)
7.Secondary Outcome
Title The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Post-Transplant
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 could 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 Day 28 through Week 52 Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 28 29 11
Mean (Standard Deviation)
Unit of Measure: eGFR change over time (by month)
0.3  (4.1) 1.3  (2.6) 0.8  (1.4)
8.Secondary Outcome
Title Count of Participants With Delayed Graft Function at Wk 52 Post-Transplant
Hide Description Delayed grafted 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 Transplantation through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 29 29 11
Measure Type: Count of Participants
Unit of Measure: Participants
6
  20.7%
9
  31.0%
0
   0.0%
9.Secondary Outcome
Title Count of Participants With Acute Cellular Rejection Grade ≥ IA Defined by Banff 2007 Criteria By Wk 52 Post-Transplant
Hide Description Acute cellular rejection occurs 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 equal to or greater than IA by Banff 2007 criteria as determined by local pathology.
Time Frame Transplantation through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 29 29 11
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.4%
10
  34.5%
4
  36.4%
10.Secondary Outcome
Title Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant
Hide Description Acute cellular rejection occurs 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 equal to or greater than IA by Banff 2007 criteria as determined by local pathology. 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 it was 2 endpoints but all participants' highest grade was also their first grade so only reporting their first grade.
Time Frame Transplantation through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 29 29 11
Measure Type: Count of Participants
Unit of Measure: Participants
IA
0
   0.0%
3
  10.3%
2
  18.2%
IB
1
   3.4%
1
   3.4%
2
  18.2%
IIA
0
   0.0%
4
  13.8%
0
   0.0%
IIB
0
   0.0%
0
   0.0%
0
   0.0%
III
0
   0.0%
2
   6.9%
0
   0.0%
11.Secondary Outcome
Title Count of Participants With Antibody Mediated Rejection by Wk 52 Post-Transplant
Hide Description Antibody mediated rejection is defined by diffusely positive staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury and was determined by local pathology.
Time Frame Transplantation through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 29 29 11
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.4%
1
   3.4%
0
   0.0%
12.Secondary Outcome
Title Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies
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 local biopsy findings are presented here for rejection. Acronyms and abbreviations are defined as follows:

  • ACR= Acute T-Cell Mediated rejection
  • AMR= Acute Antibody-mediated rejection
  • Chr. AMR=Chronic Antibody Mediated Rejection
  • Gd.=Grade
  • IFTA=Interstitial Fibrosis and Tubular Atrophy
Time Frame Transplantation through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 29 29 11
Measure Type: Number
Unit of Measure: Biopsy
Borderline 3 5 0
Borderline, AMR-Gd. I (ATN-Like) 1 0 0
Borderline, AMR-Gd.I (ATN-Like), Chr.AMR, IFTA-Gd1 1 0 0
Borderline, AMR-Gd. I (ATN-Like), IFTA-Gd. I 0 1 0
Borderline, Chr.AMR, IFTA-Gd. I 1 0 0
Borderline, IFTA-Gd. I 1 2 1
Borderline, IFTA- Gd. II 2 1 0
ACR-Gd. IA 0 4 2
ACR-Gd. IA, IFTA-Gd. I 0 1 0
ACR-Gd. IA, IFTA-Gd. II 1 0 0
ACR-Gd. IB 1 0 0
ACR-Gd. IB, IFTA-Gd. I 0 1 1
ACR-Gd. IB, IFTA-Gd. II 0 0 1
ACR-Gd. IB, IFTA-Gd. III 0 1 0
ACR-Gd. IIA 0 2 0
ACR-Gd. IIA, IFTA-Gd. I 0 2 0
ACR-Gd. III 0 2 0
AMR-Gd. II (Capillary/Glomerular) 1 0 0
IFTA-Gd. I 4 5 1
IFTA-Gd. II 1 2 0
13.Secondary Outcome
Title Type of Treatment for Detected Graft 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 treatment are presented here for rejection. Acronyms and abbreviations are defined below.

ATG=Thymoglobulin

Time Frame Transplantation through Week 52
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Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 29 29 11
Measure Type: Number
Unit of Measure: Biopsy
ATG 0 1 0
ATG, Pulse Steroids 0 5 2
ATG, Pulse Steroids, Prograf 0 1 0
Antibiotic 1 0 0
Plasmapheresis 1 0 0
Plasmapheresis, Oral Steroids 1 0 0
Pulse Steroids 6 9 3
Pulse Steroids, Leflunomide 0 1 0
Pulse Steroids, Plasmapheresis, Eculizumab 1 0 0
Prednisone 0 2 0
14.Secondary Outcome
Title Count of Participants With De Novo Anti-Donor Histocompatibility Antigen (HLA) Antibodies at Wk 52 Post-Transplant
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.

No data available.

Time Frame Week 52
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Hide Analysis Population Description
No analysis due to no available data. Data were not reported from the central laboratory and, therefore, unable to be summarized.
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Count of Participants With Either New Onset Diabetes After Transplant (NODAT) or Impaired Fasting Glucose (IFG) at Week 52 Post-Transplant -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 Transplantation through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 29 29 11
Measure Type: Count of Participants
Unit of Measure: Participants
New onset diabetes during first 52 weeks Number Analyzed 29 participants 29 participants 11 participants
1
   3.4%
1
   3.4%
0
   0.0%
Impaired fasting glucose at week 52 Number Analyzed 14 participants 15 participants 8 participants
2
  14.3%
0
   0.0%
0
   0.0%
16.Secondary Outcome
Title Count of Participants With Treated Diabetes Between Day 14 and Wk 52 Post-Transplant
Hide Description Treated diabetes is defined as receipt of any oral medication or insulin for the treatment of diabetes for >14 days.
Time Frame Day 14 through week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 26 28 11
Measure Type: Count of Participants
Unit of Measure: Participants
3
  11.5%
2
   7.1%
0
   0.0%
17.Secondary Outcome
Title Hemoglobin A1c (HbA1c) Measurements Over Time
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 Baseline (Pre-Transplant) and Days 28 and -84, and Weeks 28, -36, and -52 Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 26 28 11
Mean (Standard Deviation)
Unit of Measure: percentage
Baseline Number Analyzed 26 participants 28 participants 10 participants
5.7  (1.3) 5.7  (1.1) 5.9  (0.8)
Day 28 Number Analyzed 25 participants 27 participants 11 participants
5.4  (0.8) 5.6  (1.0) 5.4  (1.1)
Day 84 Number Analyzed 24 participants 24 participants 11 participants
5.6  (1.1) 5.5  (1.1) 5.4  (0.8)
Week 28 Number Analyzed 20 participants 17 participants 11 participants
6.2  (1.9) 6.0  (1.4) 5.6  (0.8)
Week 36 Number Analyzed 15 participants 15 participants 11 participants
6.7  (2.6) 5.9  (1.2) 5.5  (0.8)
Week 52 Number Analyzed 10 participants 9 participants 9 participants
7.8  (3.3) 6.7  (1.6) 5.8  (1.3)
18.Secondary Outcome
Title Standardized Blood Pressure Measurement at Wk 52 Post-Transplant
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 population with available data
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 26 18 3
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic BP at W52 135.0  (18.9) 133.7  (14.7) 132.0  (8.7)
Diastolic BP at W52 77.7  (10.9) 79.1  (10.2) 75.7  (13.1)
19.Secondary Outcome
Title Count of Participants With Use of Anti-hypertensive Medication at Wk 52 Post-Transplant
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 stroke and myocardial infarction.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 26 28 11
Measure Type: Count of Participants
Unit of Measure: Participants
18
  69.2%
23
  82.1%
8
  72.7%
20.Secondary Outcome
Title Fasting Lipid Profile at Baseline (Pre-Transplant)
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 provided:

  • 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 and
  • Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 22 26 7
Mean (Standard Deviation)
Unit of Measure: mg/dL
Total cholesterol Number Analyzed 22 participants 26 participants 7 participants
167.1  (37.5) 159.4  (45.0) 167.6  (84.8)
Non-HDL Number Analyzed 22 participants 26 participants 7 participants
122.0  (35.1) 116.1  (45.7) 123.4  (85.3)
LDL Number Analyzed 21 participants 25 participants 6 participants
91.1  (28.0) 83.1  (38.5) 65.2  (15.3)
HDL Number Analyzed 22 participants 26 participants 7 participants
45.1  (11.8) 43.3  (13.0) 44.1  (19.9)
Triglyceride Number Analyzed 22 participants 26 participants 7 participants
156.8  (103.6) 194.4  (171.1) 227.1  (248.1)
21.Secondary Outcome
Title Fasting Lipid Profile at Wk 28 Post-Transplant
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 provided:

  • 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 and
  • Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease.
Time Frame Week 28
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 15 15 10
Mean (Standard Deviation)
Unit of Measure: mg/dL
Total cholesterol Number Analyzed 15 participants 15 participants 10 participants
169.6  (38.6) 179.5  (44.4) 167.3  (39.5)
Non-HDL Number Analyzed 14 participants 15 participants 10 participants
119.6  (35.9) 133.5  (46.7) 115.0  (38.0)
LDL Number Analyzed 14 participants 14 participants 10 participants
95.6  (31.4) 109.8  (43.0) 82.7  (18.2)
HDL Number Analyzed 14 participants 15 participants 10 participants
51.0  (14.5) 46.0  (18.6) 52.3  (27.5)
Triglyceride Number Analyzed 14 participants 15 participants 10 participants
126.4  (51.0) 153.3  (93.0) 166.6  (128.9)
22.Secondary Outcome
Title Fasting Lipid Profile at Wk 52 Post-Transplant
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 provided:

  • 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 and
  • Triglycerides: <150 mg/dL; high values indicate risk of cardiovascular disease.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 8 9 8
Mean (Standard Deviation)
Unit of Measure: mg/dL
Total cholesterol 177.1  (25.6) 163.7  (38.8) 174.8  (54.7)
Non-HDL 128.6  (30.6) 121.2  (32.0) 130.8  (45.6)
LDL 102.9  (17.7) 86.3  (50.6) 94.6  (46.4)
HDL 48.5  (11.3) 42.4  (15.6) 44.0  (14.9)
Triglyceride 125.8  (93.0) 170.0  (118.6) 182.8  (84.2)
23.Secondary Outcome
Title Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant
Hide Description Lipid lowering medications are used in the treatment of high levels of fats (lipids), such as cholesterol in blood.
Time Frame Baseline (Pre-Transplant), Week 28, and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 29 29 11
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 29 participants 29 participants 11 participants
13
  44.8%
7
  24.1%
3
  27.3%
Week 28 Number Analyzed 27 participants 29 participants 11 participants
8
  29.6%
9
  31.0%
4
  36.4%
Week 52 Number Analyzed 26 participants 28 participants 11 participants
9
  34.6%
9
  32.1%
5
  45.5%
24.Secondary Outcome
Title Total Daily Prescribed Pill Count
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 28, Week 36, and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 28 28 11
Mean (Standard Deviation)
Unit of Measure: pills per day
Day 28 Number Analyzed 28 participants 28 participants 11 participants
25.8  (9.9) 18.9  (7.5) 23.5  (8.9)
Day 84 Number Analyzed 25 participants 26 participants 11 participants
22.2  (6.3) 17.2  (6.3) 21.0  (7.0)
Week 28 Number Analyzed 19 participants 17 participants 11 participants
19.7  (7.2) 15.5  (6.0) 16.6  (8.1)
Week 36 Number Analyzed 13 participants 14 participants 11 participants
19.1  (8.0) 15.4  (4.8) 13.9  (5.9)
Week 52 Number Analyzed 7 participants 9 participants 9 participants
24.4  (11.8) 15.7  (5.4) 13.7  (5.1)
25.Secondary Outcome
Title Count of Participant Deaths or Graft Loss by Wk 52 Post-Transplant
Hide Description This measure counts deaths and graft loss occurring at any point post transplantation. Graft loss is defined as 90 days of dialysis dependency.
Time Frame Transplantation through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 29 29 11
Measure Type: Count of Participants
Unit of Measure: Participants
2
   6.9%
0
   0.0%
0
   0.0%
26.Secondary Outcome
Title Count of Participants With Graft Rejection by Wk 52 Post-Transplant
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 Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 29 29 11
Measure Type: Count of Participants
Unit of Measure: Participants
7
  24.1%
14
  48.3%
4
  36.4%
27.Secondary Outcome
Title Count of Participants Experiencing ≥ 1 Adverse Event (AEs) or Serious Adverse Events (SAEs) by Wk 52
Hide Description Adverse events were collected systematically from enrollment through Wk 52, the last study visit. Provided are numbers of participants with ≥ 1 adverse event (serious or non-serious adverse events) by treatment arm.
Time Frame Enrollment through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 29 29 11
Measure Type: Count of Participants
Unit of Measure: Participants
Adverse Events
21
  72.4%
28
  96.6%
9
  81.8%
Serious Adverse Events
19
  65.5%
21
  72.4%
6
  54.5%
28.Secondary Outcome
Title Count of Participants With Infections Requiring Hospitalization or Systemic Therapy by Wk 52 Post-Transplant
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 or prolongation of a current hospitalization.
Time Frame Transplantation through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 29 29 11
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.4%
8
  27.6%
2
  18.2%
29.Secondary Outcome
Title Count of Participants With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia (Local Center Monitoring) as Adverse Events by Wk 52 Post-Transplant
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 the study, using participant blood samples. Displayed are counts of participants who experienced BKV and CMV viremia as adverse events by treatment arm.
Time Frame Transplantation through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 29 29 11
Measure Type: Count of Participants
Unit of Measure: Participants
BKV
0
   0.0%
4
  13.8%
1
   9.1%
CMV
1
   3.4%
6
  20.7%
1
   9.1%
30.Secondary Outcome
Title Count of Participants With Epstein-Barr Virus (EBV) Infection as Reported on the Case Report Form as Adverse Events
Hide Description Viral infections following renal transplantation, including but not limited to EBV infection, is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss.
Time Frame Transplantation through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 29 29 11
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
31.Secondary Outcome
Title Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90 mmHg Within 24 Hours of Onset of Transplant Procedure
Hide Description Temperature of >39 degrees Celsius (e.g., 102.2 degrees Fahrenheit) 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 Within 24 Hours of transplant procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept
Hide Arm/Group Description:

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Overall Number of Participants Analyzed 29 29 11
Measure Type: Count of Participants
Unit of Measure: Participants
Fever >39 Celsius
0
   0.0%
0
   0.0%
0
   0.0%
Systolic BP < 90 mmHg
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame Enrollment through end of study (up to Week 52)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept Enrolled, Not Randomized
Hide Arm/Group Description

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.

Induction:

Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days.

Maintenance:

Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84.

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Induction:

Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5.

Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3.

The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24.

Maintenance:

Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.

Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84

Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
All-Cause Mortality
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept Enrolled, Not Randomized
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/29 (6.90%)      0/29 (0.00%)      0/11 (0.00%)      0/2 (0.00%)    
Hide Serious Adverse Events
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept Enrolled, Not Randomized
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/29 (65.52%)      21/29 (72.41%)      6/11 (54.55%)      0/2 (0.00%)    
Blood and lymphatic system disorders         
Anaemia  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/11 (0.00%)  0 0/2 (0.00%)  0
Haemolytic uraemic syndrome  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Cardiac disorders         
Atrial fibrillation  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain lower  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Diarrhoea  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/11 (0.00%)  0 0/2 (0.00%)  0
Duodenal ulcer haemorrhage  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Ileus  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/11 (0.00%)  0 0/2 (0.00%)  0
Intra-abdominal haemorrhage  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Nausea  1  2/29 (6.90%)  2 1/29 (3.45%)  2 1/11 (9.09%)  1 0/2 (0.00%)  0
Pancreatitis  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/11 (0.00%)  0 0/2 (0.00%)  0
Retroperitoneal haematoma  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/11 (0.00%)  0 0/2 (0.00%)  0
Vomiting  1  2/29 (6.90%)  2 1/29 (3.45%)  2 1/11 (9.09%)  1 0/2 (0.00%)  0
General disorders         
Chest pain  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Pyrexia  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Hepatobiliary disorders         
Bile duct stone  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Immune system disorders         
Kidney transplant rejection  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/11 (9.09%)  1 0/2 (0.00%)  0
Transplant rejection  1  2/29 (6.90%)  2 8/29 (27.59%)  10 2/11 (18.18%)  2 0/2 (0.00%)  0
Infections and infestations         
Bacteraemia  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/11 (0.00%)  0 0/2 (0.00%)  0
Clostridium difficile colitis  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Cytomegalovirus infection  1  0/29 (0.00%)  0 0/29 (0.00%)  0 1/11 (9.09%)  1 0/2 (0.00%)  0
Cytomegalovirus viraemia  1  0/29 (0.00%)  0 4/29 (13.79%)  4 0/11 (0.00%)  0 0/2 (0.00%)  0
Gastroenteritis  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Gastroenteritis viral  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Peritonitis bacterial  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Pneumonia cytomegaloviral  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Polyomavirus-associated nephropathy  1  0/29 (0.00%)  0 2/29 (6.90%)  2 0/11 (0.00%)  0 0/2 (0.00%)  0
Pyelonephritis  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Septic shock  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Urinary tract infection  1  5/29 (17.24%)  5 4/29 (13.79%)  5 1/11 (9.09%)  1 0/2 (0.00%)  0
Zygomycosis  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/11 (0.00%)  0 0/2 (0.00%)  0
Injury, poisoning and procedural complications         
Arteriovenous fistula thrombosis  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/11 (0.00%)  0 0/2 (0.00%)  0
Complications of transplanted kidney  1  2/29 (6.90%)  2 4/29 (13.79%)  4 0/11 (0.00%)  0 0/2 (0.00%)  0
Gun shot wound  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/11 (0.00%)  0 0/2 (0.00%)  0
Infusion related reaction  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/11 (0.00%)  0 0/2 (0.00%)  0
Perinephric collection  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Metabolism and nutrition disorders         
Diabetes mellitus inadequate control  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/11 (0.00%)  0 0/2 (0.00%)  0
Fluid overload  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/11 (0.00%)  0 0/2 (0.00%)  0
Hyperkalaemia  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Renal and urinary disorders         
Glomerulonephritis minimal lesion  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Haematuria  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/11 (0.00%)  0 0/2 (0.00%)  0
Hydronephrosis  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Renal artery dissection  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/11 (0.00%)  0 0/2 (0.00%)  0
Renal failure acute  1  4/29 (13.79%)  4 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Renal tubular necrosis  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Reproductive system and breast disorders         
Oedema genital  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Vascular disorders         
Deep vein thrombosis  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/11 (0.00%)  0 0/2 (0.00%)  0
Hypertensive crisis  1  1/29 (3.45%)  1 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Orthostatic hypotension  1  0/29 (0.00%)  0 1/29 (3.45%)  1 0/11 (0.00%)  0 0/2 (0.00%)  0
1
Term from vocabulary, MedDRA 13.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept Enrolled, Not Randomized
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/29 (51.72%)      24/29 (82.76%)      7/11 (63.64%)      0/2 (0.00%)    
Blood and lymphatic system disorders         
Anaemia  1  7/29 (24.14%)  8 5/29 (17.24%)  5 3/11 (27.27%)  3 0/2 (0.00%)  0
Eosinophilia  1  2/29 (6.90%)  2 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Leukocytosis  1  3/29 (10.34%)  3 2/29 (6.90%)  2 1/11 (9.09%)  1 0/2 (0.00%)  0
Leukopenia  1  4/29 (13.79%)  4 3/29 (10.34%)  3 1/11 (9.09%)  1 0/2 (0.00%)  0
Cardiac disorders         
Tachycardia  1  2/29 (6.90%)  2 1/29 (3.45%)  1 0/11 (0.00%)  0 0/2 (0.00%)  0
General disorders         
Chest pain  1  2/29 (6.90%)  2 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Immune system disorders         
Transplant rejection  1  1/29 (3.45%)  2 4/29 (13.79%)  6 1/11 (9.09%)  2 0/2 (0.00%)  0
Infections and infestations         
Urinary tract infection  1  1/29 (3.45%)  3 8/29 (27.59%)  9 0/11 (0.00%)  0 0/2 (0.00%)  0
Injury, poisoning and procedural complications         
Complications of transplanted kidney  1  3/29 (10.34%)  3 8/29 (27.59%)  8 0/11 (0.00%)  0 0/2 (0.00%)  0
Investigations         
Alanine aminotransferase increased  1  0/29 (0.00%)  0 2/29 (6.90%)  2 0/11 (0.00%)  0 0/2 (0.00%)  0
White blood cell count decreased  1  4/29 (13.79%)  4 3/29 (10.34%)  4 1/11 (9.09%)  1 0/2 (0.00%)  0
Metabolism and nutrition disorders         
Fluid overload  1  2/29 (6.90%)  2 0/29 (0.00%)  0 0/11 (0.00%)  0 0/2 (0.00%)  0
Hyperkalaemia  1  5/29 (17.24%)  7 4/29 (13.79%)  5 1/11 (9.09%)  1 0/2 (0.00%)  0
Hypoglycaemia  1  0/29 (0.00%)  0 2/29 (6.90%)  2 0/11 (0.00%)  0 0/2 (0.00%)  0
Hypophosphataemia  1  1/29 (3.45%)  1 3/29 (10.34%)  3 1/11 (9.09%)  1 0/2 (0.00%)  0
Vascular disorders         
Hypertension  1  1/29 (3.45%)  1 2/29 (6.90%)  2 0/11 (0.00%)  0 0/2 (0.00%)  0
1
Term from vocabulary, MedDRA 13.1
Indicates events were collected by systematic assessment
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: NCT01856257    
Other Study ID Numbers: DAIT CTOT-16
First Submitted: May 14, 2013
First Posted: May 17, 2013
Results First Submitted: June 23, 2017
Results First Posted: August 7, 2017
Last Update Posted: December 17, 2020