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Optimization of NULOJIX® Usage Towards Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01790594
Recruitment Status : Terminated (Slow accrual within enrollment time period: projected accrual goal not achieved.)
First Posted : February 13, 2013
Results First Posted : December 7, 2017
Last Update Posted : July 20, 2021
Sponsor:
Collaborators:
Clinical Trials in Organ Transplantation
Rho Federal Systems Division, Inc.
Bristol-Myers Squibb
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
Condition Simultaneous Kidney and Pancreas Transplantation
Interventions Biological: Belatacept
Drug: methylprednisolone
Biological: Anti-thymocyte Globulin (Rabbit)
Drug: Tacrolimus
Drug: Mycophenolate mofetil
Enrollment 46
Recruitment Details Five sites in the United States recruited and enrolled 46 participants into this trial.
Pre-assignment Details  
Arm/Group Title Investigational Control Enrolled, Not Randomized
Hide Arm/Group Description Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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. Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
Period Title: Overall Study
Started 22 21 3
Completed 17 18 0
Not Completed 5 3 3
Reason Not Completed
Death             1             0             0
Physician Decision             2             1             0
Withdrawal by Subject             2             0             0
Transplant was not done             0             0             3
Terminated prior to week 76             0             2             0
Arm/Group Title Investigational Control Total
Hide Arm/Group Description Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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. Total of all reporting groups
Overall Number of Baseline Participants 22 21 43
Hide Baseline Analysis Population Description
Randomized Participants
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
21
 100.0%
43
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 21 participants 43 participants
39.7  (7.10) 38.8  (6.98) 39.3  (6.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
Female
10
  45.5%
8
  38.1%
18
  41.9%
Male
12
  54.5%
13
  61.9%
25
  58.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
Hispanic or Latino
2
   9.1%
1
   4.8%
3
   7.0%
Not Hispanic or Latino
17
  77.3%
18
  85.7%
35
  81.4%
Unknown or Not Reported
3
  13.6%
2
   9.5%
5
  11.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 21 participants 43 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   4.8%
1
   2.3%
Black or African American
3
  13.6%
5
  23.8%
8
  18.6%
White
18
  81.8%
14
  66.7%
32
  74.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   4.5%
1
   4.8%
2
   4.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 21 participants 43 participants
22 21 43
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 Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data at week 52.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73m^2
77.0  (22.6) 74.6  (19.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational, Control
Comments The p-value compares Investigational arm and control arm.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.750
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.088
Confidence Interval (2-Sided) 95%
-11.067 to 15.242
Estimation Comments [Not Specified]
2.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 Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 22 21
Measure Type: Count of Participants
Unit of Measure: Participants
5
  22.7%
5
  23.8%
3.Secondary Outcome
Title Count of Participants by CKD Stage at Wk 52 Post-Transplant
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 Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 21 21
Measure Type: Count of Participants
Unit of Measure: Participants
Stage 1
5
  23.8%
5
  23.8%
Stage 2
11
  52.4%
11
  52.4%
Stage 3A
2
   9.5%
4
  19.0%
Stage 3B
3
  14.3%
1
   4.8%
Stage 4
0
   0.0%
0
   0.0%
Stage 5
0
   0.0%
0
   0.0%
4.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 Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 22 21
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.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 Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 21 21
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73m^2
68.7  (19.5) 67.0  (17.6)
6.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
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 22 21
Mean (Standard Deviation)
Unit of Measure: eGFR change over time (by month)
0.1  (3.1) -0.1  (2.5)
7.Secondary Outcome
Title Count of Participants With Successful Discontinuation of Tacrolimus in Recipients Randomized to the Investigational Arm
Hide Description Participants achieved successful discontinuation if they were able to discontinue (e.g., off tacrolimus therapy completely) over a 4-8 weeks after tacrolimus withdrawal was initiated at week 40.
Time Frame Week 40 through week 48 Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Investigational
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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.
Overall Number of Participants Analyzed 22
Measure Type: Count of Participants
Unit of Measure: Participants
5
  22.7%
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 Transplant through Week 52 Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 22 21
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.5%
1
   4.8%
9.Secondary Outcome
Title Count of Participants With Full Pancreatic Graft Function (Insulin Independent) at Wk 52 Post-Transplant
Hide Description Participants with full pancreatic graft functions are defined as those that no longer require exogenous insulin therapy.
Time Frame Week 52 Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 21 21
Measure Type: Count of Participants
Unit of Measure: Participants
19
  90.5%
21
 100.0%
10.Secondary Outcome
Title Count of Participants With Evidence of Partial Pancreatic Graft Function at Week 52 Post-Transplant
Hide Description C-peptide is a measure of pancreatic function. The definition of partial pancreatic graft function: a fasting C-peptide levels >0.3ng.mL (0.1nmol.L) plus the participant's continued requirement for exogenous insulin or oral hypoglycemic agent(s).
Time Frame Week 52 Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 18 17
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.6%
0
   0.0%
11.Secondary Outcome
Title Count of Participants With Evidence of Pancreatic Loss at Week 52 Post-Transplant
Hide Description C-peptide is a measure of pancreatic function. The definition of pancreatic loss: a C-peptide value of <0.3 ng/mL.
Time Frame Week 52 Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 18 17
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.6%
0
   0.0%
12.Secondary Outcome
Title HbA1c at Baseline (Pre-Transplant) Through Wk 52 Post-Transplant
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, 84, and Weeks 28, 36, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 22 21
Mean (Standard Deviation)
Unit of Measure: percent
Baseline Number Analyzed 22 participants 21 participants
8.6  (1.1) 8.5  (1.9)
Day 28 Number Analyzed 21 participants 21 participants
6.0  (0.6) 6.1  (0.6)
Day 84 Number Analyzed 21 participants 17 participants
4.8  (0.7) 4.9  (0.3)
Week 28 Number Analyzed 18 participants 16 participants
5.3  (1.3) 5.2  (0.5)
Week 36 Number Analyzed 18 participants 17 participants
5.3  (1.3) 5.1  (0.6)
Week 52 Number Analyzed 18 participants 16 participants
5.5  (1.6) 5.3  (0.5)
13.Secondary Outcome
Title Fasting Blood Sugar (FBS) From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant
Hide Description

Fasting blood sugar (e.g., glucose) test is used to help diagnose diabetes, prediabetes, and gestational diabetes.

Reference fasting blood sugar (glucose) values:

  • 70 to 99 mg/dL is normal
  • 100 to 125 mg/dL is considered prediabetes
  • 126 mg/dL or higher on two separate tests is considered diabetes.
Time Frame Baseline (Pre-Transplant) and Days 28, 84, and Weeks 28, 36, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 21 19
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline Number Analyzed 21 participants 19 participants
183.3  (107.2) 217.3  (125.4)
Day 28 Number Analyzed 21 participants 18 participants
100.0  (15.3) 100.9  (20.5)
Day 84 Number Analyzed 20 participants 19 participants
96.0  (44.9) 89.7  (8.2)
Week 28 Number Analyzed 21 participants 18 participants
106.5  (84.7) 96.2  (22.6)
Week 36 Number Analyzed 21 participants 17 participants
96.0  (27.8) 87.2  (10.8)
Week 52 Number Analyzed 20 participants 19 participants
98.6  (37.5) 91.5  (12.1)
14.Secondary Outcome
Title Standardized Blood Pressure Measurement From Baseline (Pre-Transplant) Through 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 Baseline (Pre-Transplant) and Days 28, 84, and Weeks 28, 36, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 22 21
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic BP at Baseline Number Analyzed 22 participants 21 participants
161.3  (26.1) 158.3  (23.7)
Systolic BP at Day 28 Number Analyzed 22 participants 21 participants
116.9  (15.4) 112.0  (16.8)
Systolic BP at Day 84 Number Analyzed 22 participants 19 participants
126.3  (19.2) 123.8  (18.6)
Systolic BP at Week 28 Number Analyzed 20 participants 18 participants
136.1  (22.7) 126.2  (23.8)
Systolic BP at Week 36 Number Analyzed 19 participants 19 participants
133.5  (20.5) 126.7  (10.6)
Systolic BP at Week 52 Number Analyzed 17 participants 21 participants
132.0  (18.8) 127.0  (15.4)
Diastolic BP at Baseline Number Analyzed 22 participants 21 participants
82.7  (14.0) 85.2  (10.5)
Diastolic BP at Day 28 Number Analyzed 22 participants 21 participants
67.0  (8.4) 65.4  (9.2)
Diastolic BP at Day 84 Number Analyzed 22 participants 19 participants
72.8  (7.9) 73.4  (10.1)
Diastolic BP at Week 28 Number Analyzed 20 participants 18 participants
76.6  (8.8) 73.3  (10.4)
Diastolic BP at Week 36 Number Analyzed 19 participants 19 participants
76.5  (10.0) 76.8  (8.8)
Diastolic BP at Week 52 Number Analyzed 17 participants 21 participants
74.2  (8.6) 77.0  (7.6)
15.Secondary Outcome
Title Count of Participants With Use of Anti-hypertensive Medication From Baseline (Pre-Transplant) Through 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 stoke and myocardial infarction.
Time Frame Baseline (Pre-Transplant) and Days 28, 84, and Weeks 28, 36, and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 22 21
Measure Type: Number
Unit of Measure: Count of Participants
Baseline 18 19
Day 28 14 10
Day 84 11 7
Week 28 13 11
Week 36 13 11
Week 52 13 11
16.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 (Pre-Transplant)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 19 19
Mean (Standard Deviation)
Unit of Measure: mg/dL
Tot. Chol. Baseline 142.8  (38.1) 140.5  (42.0)
Non-HDL Baseline 91.0  (28.0) 82.4  (42.0)
LDL Baseline 66.5  (28.0) 60.7  (32.9)
HDL Baseline 51.8  (19.0) 58.1  (16.2)
Triglyc. Baseline 120.9  (55.2) 107.5  (55.1)
17.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 Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 17 16
Mean (Standard Deviation)
Unit of Measure: mg/dL
Tot. Chol. Week 28 159.9  (48.8) 149.2  (28.7)
Non-HDL Week 28 112.6  (45.4) 97.4  (27.9)
LDL Week 28 93.1  (43.9) 81.2  (28.5)
HDL Week 28 47.3  (15.1) 51.8  (11.8)
Triglyc. Week 28 93.2  (52.6) 87.8  (44.1)
18.Secondary Outcome
Title 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 Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 19 13
Mean (Standard Deviation)
Unit of Measure: mg/dL
Tot. Chol. Week 52 Number Analyzed 19 participants 13 participants
164.2  (38.9) 162.8  (44.1)
Non-HDL Week 52 Number Analyzed 19 participants 12 participants
115.7  (38.1) 112.3  (38.5)
LDL Week 52 Number Analyzed 19 participants 12 participants
96.9  (36.5) 92.7  (33.1)
HDL Week 52 Number Analyzed 19 participants 12 participants
48.5  (16.7) 47.3  (12.8)
Triglyc. Week 52 Number Analyzed 19 participants 12 participants
88.6  (34.9) 95.4  (75.0)
19.Secondary Outcome
Title Count of Participants With Use of Lipid Lowering Medications at Baseline, 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
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 22 21
Measure Type: Number
Unit of Measure: participants
Baseline 18 18
Week 28 19 16
Week 52 19 16
20.Secondary Outcome
Title Count of Participants With Acute Rejection (AR) of Kidney or Pancreatic Transplant During the First 52 Wks Post-Transplant
Hide Description

Biopsy-proven acute rejection (AR) of the kidney (renal) or pancreas during the first 52 weeks post-transplant. AR grading using standard Banff* criteria. For both kidney and pancreas, AR is defined as a grade ≥1.

  • AR for the kidney: Banff 2007 criteria. Severity of AR is graded by as IA, IB, IIA, IIB, or III, with IA defined as the mildest form of AR and III being the most severe.
  • AR for the pancreas: Banff 2011 Criteria. Severity of AR is graded as I, II, or III, with I defined as the mildest form of AR and III being the most severe.
Time Frame Transplant through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 22 21
Measure Type: Number
Unit of Measure: Count of Participants
Kidney 2 2
Pancreas 5 1
21.Secondary Outcome
Title Severity Grade of First Biopsy-Proven Acute Rejection (AR) During the First 52 Weeks Post-Transplant
Hide Description

AR grading using standard Banff* criteria. For both kidney and pancreas, AR is defined as a grade ≥1.

  • AR for the kidney: Banff 2007 criteria. Severity of AR is graded by as IA, IB, IIA, IIB, or III, with IA defined as the mildest form of AR and III being the most severe.
  • AR for the pancreas: Banff 2011 Criteria. Severity of AR is graded is I, II, or III, with I defined as the mildest form of AR and III being the most severe.
Time Frame Transplant through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 22 21
Measure Type: Number
Unit of Measure: Participants
Kidney First Grade IA 0 1
Kidney First Grade IB 1 0
Kidney First Grade IIA 0 1
Kidney First Grade IIB 1 0
Pancreas First Grade I 4 0
Pancreas First Grade II 1 1
22.Secondary Outcome
Title Count of Participants With Biopsy-Proven Humoral Rejection During the First 52 Weeks Post-Transplant
Hide Description

Humoral rejection (i.e., antibody mediated rejection) of:

  1. the kidney as defined by diffusely positive staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury determined by local pathology and,
  2. the pancreas as defined by the presence of circulating anti-donor antibodies, and histopathological data including morphologic evidence of microvascular tissue injury and C4d staining in interacinar capillaries determined by local pathology.
Time Frame Transplant through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 22 21
Measure Type: Number
Unit of Measure: Count of Participants
Kidney 0 0
Pancreas 0 0
23.Secondary Outcome
Title Count of Participants With De Novo Anti-Donor Antibodies or Anti-Human Leukocyte Antigen (HLA) Antibodies During the First 52 Weeks Post-Transplant
Hide Description

The de novo development of donor-specific antibody (DSA) is associated with an increased risk of graft rejection.

The presence of anti-Histocompatibility Antigen (HLA) antibodies (alloantibodies) is associated with increased risk of acute and chronic injury to the transplant allograft.

Time Frame Transplant through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 22 20
Measure Type: Number
Unit of Measure: Count of Participants
De novo DSA 0 0
Anti-HLA 2 1
24.Secondary Outcome
Title Type of Treatment(s) Participants Received for Biopsy-Proven Renal Allograft Rejection During the First 52 Weeks Post-Transplant
Hide Description

Participants are stratified by kidney biopsy results/treatment received.

In the event of a for cause renal (kidney) biopsy:

-The diagnosis of acute cellular rejection (ACR) using the Banff 2007 renal allograft pathology criteria. These criteria for renal allograft biopsies is an international histopathological classification standard. ACR is defined by a renal biopsy demonstrating a Banff 2007 classification of Grade IA or greater, with higher scores indicating more severe rejection. (Ref: Solez K, Colvin RB et al. Banff 07 classification of renal allograft pathology: updates and future directions. Am J Transplant 2008 8(4): 753-60).

Acronyms and abbreviations:

  • ACR=Acute Cellular Rejection*
  • Normal*
  • Borderline* (criteria for ACR not fulfilled)
  • Gd.=Grade*
  • IFTA=Interstitial Fibrosis and Tubular Atrophy*
  • ATG=Anti-thymocyte globulin therapy
  • IVIG=Intravenous Immunoglobulin therapy
  • PO=Orally
  • QD=Daily *Banff 2007 renal allograft pathology criteria
Time Frame Transplant through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data. All participants were considered evaluable for rejection. Only 'for cause' biopsies were performed post-transplant.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 22 21
Measure Type: Count of Participants
Unit of Measure: Participants
Borderline/None Number Analyzed 11 participants 11 participants
1
   9.1%
0
   0.0%
Borderline/Pulse Steroids Number Analyzed 11 participants 11 participants
0
   0.0%
1
   9.1%
Borderline, IFTA-Gd. I/Pulse Steroids, IVIG Number Analyzed 11 participants 11 participants
0
   0.0%
1
   9.1%
ACR-Gd. IA/ATG, Pulse Steroids Number Analyzed 11 participants 11 participants
0
   0.0%
1
   9.1%
ACR-Gd. IB/ATG, Pulse Steroids Number Analyzed 11 participants 11 participants
1
   9.1%
0
   0.0%
ACR-Gd. IIA/ATG, Pulse Steroids Number Analyzed 11 participants 11 participants
0
   0.0%
1
   9.1%
ACR-Gd. IIB/ATG, Pulse Steroids Number Analyzed 11 participants 11 participants
1
   9.1%
0
   0.0%
IFTA-Gd. I/None Number Analyzed 11 participants 11 participants
1
   9.1%
0
   0.0%
IFTA-Gd. I/Potassium citrate Number Analyzed 11 participants 11 participants
2
  18.2%
0
   0.0%
Normal/Steroids QD Number Analyzed 11 participants 11 participants
0
   0.0%
1
   9.1%
No grade reported/IVIG Number Analyzed 11 participants 11 participants
1
   9.1%
0
   0.0%
No grade reported/None Number Analyzed 22 participants 21 participants
1
   4.5%
4
  19.0%
Normal/None Number Analyzed 22 participants 21 participants
3
  13.6%
2
   9.5%
25.Secondary Outcome
Title Type of Treatment(s) Participants Received for Biopsy-Proven Pancreatic Allograft Rejection During the First 52 Weeks Post-Transplant
Hide Description

Participants are stratified by kidney biopsy results/treatment received.

Upon having a for-cause biopsy performed, persons often receive treatment for rejection based on the biopsy results, which may or may not reveal signs of rejection. Details of biopsy findings and corresponding treatment are provided for each instance of treatment for rejection.

Results summary format: biopsy results; treatment.

Acronyms and abbreviations:

  • ACR=Acute Cellular Rejection
  • IFTA=Interstitial Fibrosis and Tubular Atrophy
  • ATG=Anti-thymocyte globulin therapy
  • IVIG=Intravenous Immunoglobulin therapy
  • Gd =Grade
  • PO=Orally
  • QD=Daily
Time Frame Transplant through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data. Only 'for cause' biopsies were performed post-transplant.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 22 21
Measure Type: Count of Participants
Unit of Measure: Participants
ACR-Gd. I/ATG Number Analyzed 6 participants 1 participants
1
  16.7%
0
   0.0%
ACR-Gd. I/ATG, Pulse Steroids Number Analyzed 6 participants 1 participants
1
  16.7%
0
   0.0%
ACR-Gd. I/ATG, Pulse Steroids, IVIG Number Analyzed 6 participants 1 participants
1
  16.7%
0
   0.0%
ACR-Gd. I, IFTA-Gd. I/Pulse Steroids, Solumedrol, Number Analyzed 6 participants 1 participants
1
  16.7%
0
   0.0%
ACR-Gd. II/ATG, Pulse Steroids Number Analyzed 6 participants 1 participants
1
  16.7%
1
 100.0%
No grade reported/None Number Analyzed 22 participants 21 participants
1
   4.5%
0
   0.0%
26.Secondary Outcome
Title Count of Participants With Event of Death, Graft Loss, or Undetectable C-peptide
Hide Description

This measure counts death, graft loss, or undetectable C-peptide value (e.g., C-peptide <0.3 ng/mL) occurring at any point post-transplant and independent of each other.

  • Kidney Graft Loss was defined as 90 consecutive days of dialysis dependency.
  • Pancreas graft loss was defined as returning to exogenous insulin therapy or initiation of oral hypoglycemic agents for greater than 30 days.
  • Factitious hypoglycemia due to surreptitious insulin administration results in elevated serum insulin levels and low or undetectable C-peptide levels.
Time Frame Transplant through Week 52 Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population with available data.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 22 21
Measure Type: Count of Participants
Unit of Measure: Participants
Death
1
   4.5%
0
   0.0%
Kidney Graft Loss
0
   0.0%
0
   0.0%
Pancreas Graft Loss
1
   4.5%
0
   0.0%
Undetectable C-peptide
0
   0.0%
0
   0.0%
27.Secondary Outcome
Title Count of Participants With the Occurrence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description

Adverse events were collected systematically. Counts of all participants who experienced at least one adverse event (AEs, SAEs) by assigned treatment group.

Refer to the Serious Adverse Events and Other Adverse Events tables for more detail.

Time Frame From Enrollment (Pre-Transplant) to Week 52 Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 22 21
Measure Type: Number
Unit of Measure: Count of Participants
All Adverse Events 22 21
Serious Adverse Events 20 19
28.Secondary Outcome
Title Count of Participants With an Infectious Disease Serious Adverse Event(s) Requiring Hospitalization or Systemic Therapy
Hide Description Infections were required to be reported as a serious adverse event if they required either inpatient hospitalization or prolongation of a current hospitalization. Displayed are counts of all participants who experienced infection(s) as an adverse event, by treatment group.
Time Frame Transplant through Week 52 Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 22 21
Measure Type: Count of Participants
Unit of Measure: Participants
11
  50.0%
11
  52.4%
29.Secondary Outcome
Title Count of Participant Diagnosed With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia As Adverse Events
Hide Description

Viral infections following renal transplantation is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss.

Specific viruses were monitored during this study using participant blood samples. Displayed are counts of participants who experienced BKV and CMV viremia as adverse events, diagnosed by test results from the local clinical pathology laboratory.

Time Frame Transplant through Week 52 Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 22 21
Measure Type: Number
Unit of Measure: Count of Participants
BK Viremia 8 3
CMV Viremia 5 3
30.Secondary Outcome
Title Count of Participants Diagnosed With Epstein-Barr Virus (EBV) Infection as an Adverse Event
Hide Description Viral infections following renal transplantation is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during this study using participant blood samples. Displayed are counts of all participants diagnosed with EBV infection as an adverse event by EBV test(s), diagnosed by test results from the local clinical pathology laboratory.
Time Frame Transplant through Week 52 Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 22 21
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
31.Secondary Outcome
Title Count of Participants Diagnosed With Malignancy as an Adverse Event
Hide Description An increased risk/incidence of malignancy is a recognized complication of immunosuppression in recipients of organ transplants. In Phase 3 clinical trials, overall malignancy rates were similar across all treatment groups, with the exception of posttransplant lymphoproliferative disease (PTLD).Displayed are counts of all participants who experienced malignancy reported as an adverse event.
Time Frame Transplant through Week 52 Post-Transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population
Arm/Group Title Investigational Control
Hide Arm/Group Description:
Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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.
Overall Number of Participants Analyzed 22 21
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame Transplantation until end of study (up to 76 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Investigational Control Enrolled, Not Randomized
Hide Arm/Group Description Induction: Methylprednisolone (MEDROL) was administered at a dose of 500 mg 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg on days 5, 14, 28, 56, and 84. After 84 days participants received 5 mg/kg every 4 weeks until the completion of the trial. Site investigator determined the initial dose of tacrolimus (tac) started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 5-8 ng/ml during the first 24 weeks, and adjusted to 3-5 ng/ml until week 40. If eligible, at week 40 tac withdrawal was initiated over a 4-8 week period. 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: 500 mg of MEDROL was administered 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. A target dose of 6 mg/kg over 3 to 4 days of Thymoglobulin was administered via intravenous infusion. Maintenance: Site investigator determined the initial dose of tacrolimus (tac) that started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks, and adjusted to 5-8 ng/ml thereafter. 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. Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
All-Cause Mortality
Investigational Control Enrolled, Not Randomized
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/22 (4.55%)      0/21 (0.00%)      0/3 (0.00%)    
Hide Serious Adverse Events
Investigational Control Enrolled, Not Randomized
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/22 (90.91%)      19/21 (90.48%)      0/3 (0.00%)    
Blood and lymphatic system disorders       
Anaemia  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Febrile neutropenia  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Cardiac disorders       
Acute myocardial infarction  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Pulseless electrical activity  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Abdominal pain lower  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Ascites  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Constipation  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Diarrhoea  1  2/22 (9.09%)  2 1/21 (4.76%)  1 0/3 (0.00%)  0
Enterocolitis haemorrhagic  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal haemorrhage  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Gastrooesophageal reflux disease  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Ileus  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Impaired gastric emptying  1  0/22 (0.00%)  0 2/21 (9.52%)  2 0/3 (0.00%)  0
Nausea  1  2/22 (9.09%)  2 1/21 (4.76%)  1 0/3 (0.00%)  0
Oesophagitis  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Pancreatitis  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Small intestinal obstruction  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Volvulus of small bowel  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Vomiting  1  2/22 (9.09%)  2 1/21 (4.76%)  1 0/3 (0.00%)  0
General disorders       
Pyrexia  1  2/22 (9.09%)  2 1/21 (4.76%)  1 0/3 (0.00%)  0
Immune system disorders       
Kidney transplant rejection  1  1/22 (4.55%)  1 3/21 (14.29%)  3 0/3 (0.00%)  0
Pancreas transplant rejection  1  7/22 (31.82%)  7 3/21 (14.29%)  4 0/3 (0.00%)  0
Renal and pancreas transplant rejection  1  2/22 (9.09%)  2 0/21 (0.00%)  0 0/3 (0.00%)  0
Infections and infestations       
Bacteraemia  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Cellulitis  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Clostridial infection  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Cytomegalovirus viraemia  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Gangrene  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Gastroenteritis  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Haematoma infection  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Infection  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Influenza  1  0/22 (0.00%)  0 2/21 (9.52%)  2 0/3 (0.00%)  0
Meningitis viral  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Oesophageal candidiasis  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Pancreas infection  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Pancreatic abscess  1  1/22 (4.55%)  1 1/21 (4.76%)  1 0/3 (0.00%)  0
Parvovirus infection  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Pneumocystis jiroveci pneumonia  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Pneumonia  1  1/22 (4.55%)  2 0/21 (0.00%)  0 0/3 (0.00%)  0
Pyelonephritis  1  0/22 (0.00%)  0 2/21 (9.52%)  2 0/3 (0.00%)  0
Sepsis  1  0/22 (0.00%)  0 1/21 (4.76%)  2 0/3 (0.00%)  0
Urinary tract infection  1  3/22 (13.64%)  3 4/21 (19.05%)  6 0/3 (0.00%)  0
Urinary tract infection bacterial  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Urosepsis  1  2/22 (9.09%)  2 0/21 (0.00%)  0 0/3 (0.00%)  0
Viral upper respiratory tract infection  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Wound infection staphylococcal  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Injury, poisoning and procedural complications       
Anastomotic haemorrhage  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Chemical burn of skin  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Contusion  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Peripancreatic fluid collection  1  2/22 (9.09%)  2 1/21 (4.76%)  1 0/3 (0.00%)  0
Post procedural haematoma  1  2/22 (9.09%)  2 0/21 (0.00%)  0 0/3 (0.00%)  0
Renal transplant torsion  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Tibia fracture  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Toxicity to various agents  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Vascular pseudoaneurysm  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Investigations       
Blood creatinine increased  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration  1  0/22 (0.00%)  0 3/21 (14.29%)  3 0/3 (0.00%)  0
Failure to thrive  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Nervous system disorders       
Diabetic autonomic neuropathy  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Renal and urinary disorders       
Neurogenic bladder  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Renal tubular necrosis  1  0/22 (0.00%)  0 1/21 (4.76%)  1 0/3 (0.00%)  0
Ureteric stenosis  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Urinary retention  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders       
Skin ulcer  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Vascular disorders       
Arteriovenous fistula  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
Orthostatic hypotension  1  1/22 (4.55%)  1 1/21 (4.76%)  1 0/3 (0.00%)  0
Peripheral ischaemia  1  1/22 (4.55%)  1 0/21 (0.00%)  0 0/3 (0.00%)  0
1
Term from vocabulary, MedDRA 15.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Investigational Control Enrolled, Not Randomized
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/22 (90.91%)      19/21 (90.48%)      0/3 (0.00%)    
Blood and lymphatic system disorders       
Anaemia  1  6/22 (27.27%)  6 10/21 (47.62%)  11 0/3 (0.00%)  0
Leukocytosis  1  0/22 (0.00%)  0 2/21 (9.52%)  4 0/3 (0.00%)  0
Leukopenia  1  6/22 (27.27%)  7 3/21 (14.29%)  6 0/3 (0.00%)  0
Thrombocytopenia  1  1/22 (4.55%)  1 5/21 (23.81%)  5 0/3 (0.00%)  0
Gastrointestinal disorders       
Gastrointestinal haemorrhage  1  0/22 (0.00%)  0 2/21 (9.52%)  2 0/3 (0.00%)  0
Infections and infestations       
BK virus infection  1  8/22 (36.36%)  8 3/21 (14.29%)  3 0/3 (0.00%)  0
Clostridial infection  1  2/22 (9.09%)  2 3/21 (14.29%)  4 0/3 (0.00%)  0
Cytomegalovirus infection  1  1/22 (4.55%)  1 2/21 (9.52%)  2 0/3 (0.00%)  0
Cytomegalovirus viraemia  1  3/22 (13.64%)  6 1/21 (4.76%)  1 0/3 (0.00%)  0
Oesophageal candidiasis  1  2/22 (9.09%)  2 1/21 (4.76%)  1 0/3 (0.00%)  0
Urinary tract infection  1  8/22 (36.36%)  12 3/21 (14.29%)  4 0/3 (0.00%)  0
Injury, poisoning and procedural complications       
Toxicity to various agents  1  0/22 (0.00%)  0 3/21 (14.29%)  3 0/3 (0.00%)  0
Investigations       
Amylase increased  1  0/22 (0.00%)  0 2/21 (9.52%)  2 0/3 (0.00%)  0
Blood creatinine increased  1  3/22 (13.64%)  4 3/21 (14.29%)  4 0/3 (0.00%)  0
Lipase increased  1  1/22 (4.55%)  1 3/21 (14.29%)  3 0/3 (0.00%)  0
Weight increased  1  2/22 (9.09%)  2 0/21 (0.00%)  0 0/3 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration  1  1/22 (4.55%)  1 2/21 (9.52%)  2 0/3 (0.00%)  0
Hyperkalaemia  1  3/22 (13.64%)  3 5/21 (23.81%)  6 0/3 (0.00%)  0
Hypoalbuminaemia  1  1/22 (4.55%)  2 2/21 (9.52%)  2 0/3 (0.00%)  0
Hypokalaemia  1  1/22 (4.55%)  1 2/21 (9.52%)  2 0/3 (0.00%)  0
Renal and urinary disorders       
Renal failure acute  1  2/22 (9.09%)  2 3/21 (14.29%)  3 0/3 (0.00%)  0
Urinary retention  1  0/22 (0.00%)  0 2/21 (9.52%)  2 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders       
Skin ulcer  1  2/22 (9.09%)  2 0/21 (0.00%)  0 0/3 (0.00%)  0
Vascular disorders       
Hypotension  1  2/22 (9.09%)  3 2/21 (9.52%)  3 0/3 (0.00%)  0
1
Term from vocabulary, MedDRA 15.1
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: NCT01790594    
Other Study ID Numbers: DAIT CTOT-15
U01AI084150 ( U.S. NIH Grant/Contract )
NIAID CRMS ID#: 20117 ( Other Identifier: DAIT NIAID )
SDY1433 ( Other Identifier: ImmPort )
First Submitted: February 11, 2013
First Posted: February 13, 2013
Results First Submitted: October 6, 2017
Results First Posted: December 7, 2017
Last Update Posted: July 20, 2021