Trial Outcomes & Findings for Optimization of NULOJIX® Usage Towards Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation (NCT NCT01790594)

NCT ID: NCT01790594

Last Updated: 2021-07-20

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 46 participants
• Primary outcome timeframe: Week 52 Post-Transplant
• Results posted on: 2021-07-20

Participant Flow

Five sites in the United States recruited and enrolled 46 participants into this trial.

Participant milestones

Measure	Investigational 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.	Control 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.	Enrolled, Not Randomized Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
Overall Study STARTED	22	21	3
Overall Study COMPLETED	17	18	0
Overall Study NOT COMPLETED	5	3	3

Reasons for withdrawal

Measure	Investigational 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.	Control 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.	Enrolled, Not Randomized Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
Overall Study Death	1	0	0
Overall Study Physician Decision	2	1	0
Overall Study Withdrawal by Subject	2	0	0
Overall Study Transplant was not done	0	0	3
Overall Study Terminated prior to week 76	0	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Investigational n=22 Participants 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.	Control n=21 Participants 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 n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	39.7 years STANDARD_DEVIATION 7.10 • n=5 Participants	38.8 years STANDARD_DEVIATION 6.98 • n=7 Participants	39.3 years STANDARD_DEVIATION 6.97 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	14 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	21 participants n=7 Participants	43 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 52 Post-Transplant

Population: Intent-to-treat population with available data at week 52.

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.

Outcome measures

Measure	Investigational n=21 Participants 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.	Control n=21 Participants 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.
Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant	77.0 mL/min/1.73m^2 Standard Deviation 22.6	74.6 mL/min/1.73m^2 Standard Deviation 19.7

SECONDARY outcome

Timeframe: Week 52 Post-Transplant

Population: Intent-to-treat population

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.

Outcome measures

Measure	Investigational n=22 Participants 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.	Control n=21 Participants 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.
Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant	5 Participants	5 Participants

SECONDARY outcome

Timeframe: Week 52 Post-Transplant

Population: Intent-to-treat population

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.*

Outcome measures

Measure	Investigational n=21 Participants 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.	Control n=21 Participants 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.
Count of Participants by CKD Stage at Wk 52 Post-Transplant Stage 1	5 Participants	5 Participants
Count of Participants by CKD Stage at Wk 52 Post-Transplant Stage 2	11 Participants	11 Participants
Count of Participants by CKD Stage at Wk 52 Post-Transplant Stage 3A	2 Participants	4 Participants
Count of Participants by CKD Stage at Wk 52 Post-Transplant Stage 3B	3 Participants	1 Participants
Count of Participants by CKD Stage at Wk 52 Post-Transplant Stage 4	0 Participants	0 Participants
Count of Participants by CKD Stage at Wk 52 Post-Transplant Stage 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 52 Post-Transplant

Population: Intent-to-treat population

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.*

Outcome measures

Measure	Investigational n=22 Participants 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.	Control n=21 Participants 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.
Count of Participants With Defined CKD Stage 4 or 5 at Wk 52 Post-Transplant	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 52 Post-Transplant

Population: Intent-to-treat population

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.

Outcome measures

Measure	Investigational n=21 Participants 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.	Control n=21 Participants 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.
Mean Calculated eGFR Using MDRD 4 Variable Model at Wk 52 Post-Transplant	68.7 mL/min/1.73m^2 Standard Deviation 19.5	67.0 mL/min/1.73m^2 Standard Deviation 17.6

SECONDARY outcome

Timeframe: Day 28 through Week 52 Post-Transplant

Population: Intent-to-treat population

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.

Outcome measures

Measure	Investigational n=22 Participants 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.	Control n=21 Participants 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.
The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Post-Transplant	0.1 eGFR change over time (by month) Standard Deviation 3.1	-0.1 eGFR change over time (by month) Standard Deviation 2.5

SECONDARY outcome

Timeframe: Week 40 through week 48 Post-Transplant

Population: Intent-to-treat population with available data

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.

Outcome measures

Measure	Investigational n=22 Participants 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.	Control 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.
Count of Participants With Successful Discontinuation of Tacrolimus in Recipients Randomized to the Investigational Arm	5 Participants	—

SECONDARY outcome

Timeframe: Transplant through Week 52 Post-Transplant

Population: Intent-to-treat population

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.

Outcome measures

Measure	Investigational n=22 Participants 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.	Control n=21 Participants 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.
Count of Participants With Delayed Graft Function at Wk 52 Post-Transplant	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 52 Post-Transplant

Population: Intent-to-treat population

Participants with full pancreatic graft functions are defined as those that no longer require exogenous insulin therapy.

Outcome measures

Measure	Investigational n=21 Participants 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.	Control n=21 Participants 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.
Count of Participants With Full Pancreatic Graft Function (Insulin Independent) at Wk 52 Post-Transplant	19 Participants	21 Participants

SECONDARY outcome

Timeframe: Week 52 Post-Transplant

Population: Intent-to-treat population with available data

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).

Outcome measures

Measure	Investigational n=18 Participants 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.	Control n=17 Participants 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.
Count of Participants With Evidence of Partial Pancreatic Graft Function at Week 52 Post-Transplant	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 52 Post-Transplant

Population: Intent-to-treat population with available data

C-peptide is a measure of pancreatic function. The definition of pancreatic loss: a C-peptide value of <0.3 ng/mL.

Outcome measures

Measure	Investigational n=18 Participants 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.	Control n=17 Participants 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.
Count of Participants With Evidence of Pancreatic Loss at Week 52 Post-Transplant	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Pre-Transplant) and Days 28, 84, and Weeks 28, 36, and 52

Population: Intent-to-treat population with available data

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.

Outcome measures

Measure	Investigational n=22 Participants 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.	Control n=21 Participants 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.
HbA1c at Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Baseline	8.6 percent Standard Deviation 1.1	8.5 percent Standard Deviation 1.9
HbA1c at Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Day 28	6.0 percent Standard Deviation 0.6	6.1 percent Standard Deviation 0.6
HbA1c at Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Day 84	4.8 percent Standard Deviation 0.7	4.9 percent Standard Deviation 0.3
HbA1c at Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Week 28	5.3 percent Standard Deviation 1.3	5.2 percent Standard Deviation 0.5
HbA1c at Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Week 36	5.3 percent Standard Deviation 1.3	5.1 percent Standard Deviation 0.6
HbA1c at Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Week 52	5.5 percent Standard Deviation 1.6	5.3 percent Standard Deviation 0.5

SECONDARY outcome

Timeframe: Baseline (Pre-Transplant) and Days 28, 84, and Weeks 28, 36, and 52

Population: Intent-to-treat population with available data

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.

Outcome measures

Measure	Investigational n=21 Participants 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.	Control n=19 Participants 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.
Fasting Blood Sugar (FBS) From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Baseline	183.3 mg/dL Standard Deviation 107.2	217.3 mg/dL Standard Deviation 125.4
Fasting Blood Sugar (FBS) From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Day 28	100.0 mg/dL Standard Deviation 15.3	100.9 mg/dL Standard Deviation 20.5
Fasting Blood Sugar (FBS) From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Day 84	96.0 mg/dL Standard Deviation 44.9	89.7 mg/dL Standard Deviation 8.2
Fasting Blood Sugar (FBS) From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Week 28	106.5 mg/dL Standard Deviation 84.7	96.2 mg/dL Standard Deviation 22.6
Fasting Blood Sugar (FBS) From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Week 36	96.0 mg/dL Standard Deviation 27.8	87.2 mg/dL Standard Deviation 10.8
Fasting Blood Sugar (FBS) From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Week 52	98.6 mg/dL Standard Deviation 37.5	91.5 mg/dL Standard Deviation 12.1

SECONDARY outcome

Timeframe: Baseline (Pre-Transplant) and Days 28, 84, and Weeks 28, 36, and 52

Population: Intent-to-treat population with available data

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.

Outcome measures

Measure	Investigational n=22 Participants 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.	Control n=21 Participants 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.
Standardized Blood Pressure Measurement From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Systolic BP at Week 52	132.0 mmHg Standard Deviation 18.8	127.0 mmHg Standard Deviation 15.4
Standardized Blood Pressure Measurement From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Diastolic BP at Baseline	82.7 mmHg Standard Deviation 14.0	85.2 mmHg Standard Deviation 10.5
Standardized Blood Pressure Measurement From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Diastolic BP at Day 28	67.0 mmHg Standard Deviation 8.4	65.4 mmHg Standard Deviation 9.2
Standardized Blood Pressure Measurement From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Systolic BP at Baseline	161.3 mmHg Standard Deviation 26.1	158.3 mmHg Standard Deviation 23.7
Standardized Blood Pressure Measurement From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Systolic BP at Day 28	116.9 mmHg Standard Deviation 15.4	112.0 mmHg Standard Deviation 16.8
Standardized Blood Pressure Measurement From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Systolic BP at Day 84	126.3 mmHg Standard Deviation 19.2	123.8 mmHg Standard Deviation 18.6
Standardized Blood Pressure Measurement From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Systolic BP at Week 28	136.1 mmHg Standard Deviation 22.7	126.2 mmHg Standard Deviation 23.8
Standardized Blood Pressure Measurement From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Systolic BP at Week 36	133.5 mmHg Standard Deviation 20.5	126.7 mmHg Standard Deviation 10.6
Standardized Blood Pressure Measurement From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Diastolic BP at Day 84	72.8 mmHg Standard Deviation 7.9	73.4 mmHg Standard Deviation 10.1
Standardized Blood Pressure Measurement From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Diastolic BP at Week 28	76.6 mmHg Standard Deviation 8.8	73.3 mmHg Standard Deviation 10.4
Standardized Blood Pressure Measurement From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Diastolic BP at Week 36	76.5 mmHg Standard Deviation 10.0	76.8 mmHg Standard Deviation 8.8
Standardized Blood Pressure Measurement From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Diastolic BP at Week 52	74.2 mmHg Standard Deviation 8.6	77.0 mmHg Standard Deviation 7.6

SECONDARY outcome

Timeframe: Baseline (Pre-Transplant) and Days 28, 84, and Weeks 28, 36, and 52

Population: Intent-to-treat population with available data

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.

Outcome measures

Measure	Investigational n=22 Participants 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.	Control n=21 Participants 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.
Count of Participants With Use of Anti-hypertensive Medication From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Baseline	18 Count of Participants	19 Count of Participants
Count of Participants With Use of Anti-hypertensive Medication From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Day 28	14 Count of Participants	10 Count of Participants
Count of Participants With Use of Anti-hypertensive Medication From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Day 84	11 Count of Participants	7 Count of Participants
Count of Participants With Use of Anti-hypertensive Medication From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Week 28	13 Count of Participants	11 Count of Participants
Count of Participants With Use of Anti-hypertensive Medication From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Week 36	13 Count of Participants	11 Count of Participants
Count of Participants With Use of Anti-hypertensive Medication From Baseline (Pre-Transplant) Through Wk 52 Post-Transplant Week 52	13 Count of Participants	11 Count of Participants

SECONDARY outcome

Timeframe: Baseline (Pre-Transplant)

Population: Intent-to-treat population with available data

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.

Outcome measures

Measure	Investigational n=19 Participants 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.	Control n=19 Participants 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.
Fasting Lipid Profile at Baseline (Pre-Transplant) Tot. Chol. Baseline	142.8 mg/dL Standard Deviation 38.1	140.5 mg/dL Standard Deviation 42.0
Fasting Lipid Profile at Baseline (Pre-Transplant) Non-HDL Baseline	91.0 mg/dL Standard Deviation 28.0	82.4 mg/dL Standard Deviation 42.0
Fasting Lipid Profile at Baseline (Pre-Transplant) LDL Baseline	66.5 mg/dL Standard Deviation 28.0	60.7 mg/dL Standard Deviation 32.9
Fasting Lipid Profile at Baseline (Pre-Transplant) HDL Baseline	51.8 mg/dL Standard Deviation 19.0	58.1 mg/dL Standard Deviation 16.2
Fasting Lipid Profile at Baseline (Pre-Transplant) Triglyc. Baseline	120.9 mg/dL Standard Deviation 55.2	107.5 mg/dL Standard Deviation 55.1

SECONDARY outcome

Timeframe: Week 28 Post-Transplant

Population: Intent-to-treat population with available data

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.

Outcome measures

Measure	Investigational n=17 Participants 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.	Control n=16 Participants 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.
Fasting Lipid Profile at Wk 28 Post-Transplant Tot. Chol. Week 28	159.9 mg/dL Standard Deviation 48.8	149.2 mg/dL Standard Deviation 28.7
Fasting Lipid Profile at Wk 28 Post-Transplant Non-HDL Week 28	112.6 mg/dL Standard Deviation 45.4	97.4 mg/dL Standard Deviation 27.9
Fasting Lipid Profile at Wk 28 Post-Transplant LDL Week 28	93.1 mg/dL Standard Deviation 43.9	81.2 mg/dL Standard Deviation 28.5
Fasting Lipid Profile at Wk 28 Post-Transplant HDL Week 28	47.3 mg/dL Standard Deviation 15.1	51.8 mg/dL Standard Deviation 11.8
Fasting Lipid Profile at Wk 28 Post-Transplant Triglyc. Week 28	93.2 mg/dL Standard Deviation 52.6	87.8 mg/dL Standard Deviation 44.1

SECONDARY outcome

Timeframe: Week 52 Post-Transplant

Population: Intent-to-treat population with available data

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.

Outcome measures

Measure	Investigational n=19 Participants 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.	Control n=13 Participants 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.
Lipid Profile at Wk 52 Post-Transplant Tot. Chol. Week 52	164.2 mg/dL Standard Deviation 38.9	162.8 mg/dL Standard Deviation 44.1
Lipid Profile at Wk 52 Post-Transplant Non-HDL Week 52	115.7 mg/dL Standard Deviation 38.1	112.3 mg/dL Standard Deviation 38.5
Lipid Profile at Wk 52 Post-Transplant LDL Week 52	96.9 mg/dL Standard Deviation 36.5	92.7 mg/dL Standard Deviation 33.1
Lipid Profile at Wk 52 Post-Transplant HDL Week 52	48.5 mg/dL Standard Deviation 16.7	47.3 mg/dL Standard Deviation 12.8
Lipid Profile at Wk 52 Post-Transplant Triglyc. Week 52	88.6 mg/dL Standard Deviation 34.9	95.4 mg/dL Standard Deviation 75.0

SECONDARY outcome

Timeframe: Baseline (Pre-Transplant), Week 28, and Week 52

Population: Intent-to-treat population

Lipid lowering medications are used in the treatment of high levels of fats (lipids), such as cholesterol in blood

Outcome measures

Measure	Investigational n=22 Participants 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.	Control n=21 Participants 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.
Count of Participants With Use of Lipid Lowering Medications at Baseline, Wk 28 and Wk 52 Post-Transplant Baseline	18 participants	18 participants
Count of Participants With Use of Lipid Lowering Medications at Baseline, Wk 28 and Wk 52 Post-Transplant Week 28	19 participants	16 participants
Count of Participants With Use of Lipid Lowering Medications at Baseline, Wk 28 and Wk 52 Post-Transplant Week 52	19 participants	16 participants

SECONDARY outcome

Timeframe: Transplant through Week 52

Population: Intent-to-treat population

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.

Outcome measures

Measure	Investigational n=22 Participants 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.	Control n=21 Participants 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.
Count of Participants With Acute Rejection (AR) of Kidney or Pancreatic Transplant During the First 52 Wks Post-Transplant Kidney	2 Count of Participants	2 Count of Participants
Count of Participants With Acute Rejection (AR) of Kidney or Pancreatic Transplant During the First 52 Wks Post-Transplant Pancreas	5 Count of Participants	1 Count of Participants

SECONDARY outcome

Timeframe: Transplant through Week 52

Population: Intent-to-treat population

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.

Outcome measures

Measure	Investigational n=22 Participants 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.	Control n=21 Participants 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.
Severity Grade of First Biopsy-Proven Acute Rejection (AR) During the First 52 Weeks Post-Transplant Kidney First Grade IA	0 Participants	1 Participants
Severity Grade of First Biopsy-Proven Acute Rejection (AR) During the First 52 Weeks Post-Transplant Kidney First Grade IB	1 Participants	0 Participants
Severity Grade of First Biopsy-Proven Acute Rejection (AR) During the First 52 Weeks Post-Transplant Kidney First Grade IIA	0 Participants	1 Participants
Severity Grade of First Biopsy-Proven Acute Rejection (AR) During the First 52 Weeks Post-Transplant Kidney First Grade IIB	1 Participants	0 Participants
Severity Grade of First Biopsy-Proven Acute Rejection (AR) During the First 52 Weeks Post-Transplant Pancreas First Grade I	4 Participants	0 Participants
Severity Grade of First Biopsy-Proven Acute Rejection (AR) During the First 52 Weeks Post-Transplant Pancreas First Grade II	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Transplant through Week 52

Population: Intent-to-treat population with available data

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.

Outcome measures

Measure	Investigational n=22 Participants 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.	Control n=21 Participants 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.
Count of Participants With Biopsy-Proven Humoral Rejection During the First 52 Weeks Post-Transplant Kidney	0 Count of Participants	0 Count of Participants
Count of Participants With Biopsy-Proven Humoral Rejection During the First 52 Weeks Post-Transplant Pancreas	0 Count of Participants	0 Count of Participants

SECONDARY outcome

Timeframe: Transplant through Week 52

Population: Intent-to-treat population with available data

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.

Outcome measures

Measure	Investigational n=22 Participants 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.	Control n=20 Participants 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.
Count of Participants With De Novo Anti-Donor Antibodies or Anti-Human Leukocyte Antigen (HLA) Antibodies During the First 52 Weeks Post-Transplant De novo DSA	0 Count of Participants	0 Count of Participants
Count of Participants With De Novo Anti-Donor Antibodies or Anti-Human Leukocyte Antigen (HLA) Antibodies During the First 52 Weeks Post-Transplant Anti-HLA	2 Count of Participants	1 Count of Participants

SECONDARY outcome

Timeframe: Transplant through Week 52

Population: Intent-to-treat population with available data. All participants were considered evaluable for rejection. Only 'for cause' biopsies were performed post-transplant.

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

Outcome measures

Measure	Investigational n=22 Participants 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.	Control n=21 Participants 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.
Type of Treatment(s) Participants Received for Biopsy-Proven Renal Allograft Rejection During the First 52 Weeks Post-Transplant Borderline/None	1 Participants	0 Participants
Type of Treatment(s) Participants Received for Biopsy-Proven Renal Allograft Rejection During the First 52 Weeks Post-Transplant Borderline/Pulse Steroids	0 Participants	1 Participants
Type of Treatment(s) Participants Received for Biopsy-Proven Renal Allograft Rejection During the First 52 Weeks Post-Transplant Borderline, IFTA-Gd. I/Pulse Steroids, IVIG	0 Participants	1 Participants
Type of Treatment(s) Participants Received for Biopsy-Proven Renal Allograft Rejection During the First 52 Weeks Post-Transplant ACR-Gd. IA/ATG, Pulse Steroids	0 Participants	1 Participants
Type of Treatment(s) Participants Received for Biopsy-Proven Renal Allograft Rejection During the First 52 Weeks Post-Transplant ACR-Gd. IB/ATG, Pulse Steroids	1 Participants	0 Participants
Type of Treatment(s) Participants Received for Biopsy-Proven Renal Allograft Rejection During the First 52 Weeks Post-Transplant ACR-Gd. IIA/ATG, Pulse Steroids	0 Participants	1 Participants
Type of Treatment(s) Participants Received for Biopsy-Proven Renal Allograft Rejection During the First 52 Weeks Post-Transplant ACR-Gd. IIB/ATG, Pulse Steroids	1 Participants	0 Participants
Type of Treatment(s) Participants Received for Biopsy-Proven Renal Allograft Rejection During the First 52 Weeks Post-Transplant IFTA-Gd. I/None	1 Participants	0 Participants
Type of Treatment(s) Participants Received for Biopsy-Proven Renal Allograft Rejection During the First 52 Weeks Post-Transplant IFTA-Gd. I/Potassium citrate	2 Participants	0 Participants
Type of Treatment(s) Participants Received for Biopsy-Proven Renal Allograft Rejection During the First 52 Weeks Post-Transplant Normal/Steroids QD	0 Participants	1 Participants
Type of Treatment(s) Participants Received for Biopsy-Proven Renal Allograft Rejection During the First 52 Weeks Post-Transplant No grade reported/IVIG	1 Participants	0 Participants
Type of Treatment(s) Participants Received for Biopsy-Proven Renal Allograft Rejection During the First 52 Weeks Post-Transplant No grade reported/None	1 Participants	4 Participants
Type of Treatment(s) Participants Received for Biopsy-Proven Renal Allograft Rejection During the First 52 Weeks Post-Transplant Normal/None	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Transplant through Week 52

Population: Intent-to-treat population with available data. Only 'for cause' biopsies were performed post-transplant.

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

Outcome measures

Measure	Investigational n=22 Participants 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.	Control n=21 Participants 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.
Type of Treatment(s) Participants Received for Biopsy-Proven Pancreatic Allograft Rejection During the First 52 Weeks Post-Transplant ACR-Gd. I/ATG	1 Participants	0 Participants
Type of Treatment(s) Participants Received for Biopsy-Proven Pancreatic Allograft Rejection During the First 52 Weeks Post-Transplant ACR-Gd. I/ATG, Pulse Steroids	1 Participants	0 Participants
Type of Treatment(s) Participants Received for Biopsy-Proven Pancreatic Allograft Rejection During the First 52 Weeks Post-Transplant ACR-Gd. I/ATG, Pulse Steroids, IVIG	1 Participants	0 Participants
Type of Treatment(s) Participants Received for Biopsy-Proven Pancreatic Allograft Rejection During the First 52 Weeks Post-Transplant ACR-Gd. I, IFTA-Gd. I/Pulse Steroids, Solumedrol,	1 Participants	0 Participants
Type of Treatment(s) Participants Received for Biopsy-Proven Pancreatic Allograft Rejection During the First 52 Weeks Post-Transplant ACR-Gd. II/ATG, Pulse Steroids	1 Participants	1 Participants
Type of Treatment(s) Participants Received for Biopsy-Proven Pancreatic Allograft Rejection During the First 52 Weeks Post-Transplant No grade reported/None	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Transplant through Week 52 Post-Transplant

Population: Intent-to-treat population with available data.

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.

Outcome measures

Measure	Investigational n=22 Participants 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.	Control n=21 Participants 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.
Count of Participants With Event of Death, Graft Loss, or Undetectable C-peptide Death	1 Participants	0 Participants
Count of Participants With Event of Death, Graft Loss, or Undetectable C-peptide Kidney Graft Loss	0 Participants	0 Participants
Count of Participants With Event of Death, Graft Loss, or Undetectable C-peptide Pancreas Graft Loss	1 Participants	0 Participants
Count of Participants With Event of Death, Graft Loss, or Undetectable C-peptide Undetectable C-peptide	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Enrollment (Pre-Transplant) to Week 52 Post-Transplant

Population: Intent-to-treat population

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.

Outcome measures

Measure	Investigational n=22 Participants 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.	Control n=21 Participants 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.
Count of Participants With the Occurrence of Adverse Events (AEs) and Serious Adverse Events (SAEs) All Adverse Events	22 Count of Participants	21 Count of Participants
Count of Participants With the Occurrence of Adverse Events (AEs) and Serious Adverse Events (SAEs) Serious Adverse Events	20 Count of Participants	19 Count of Participants

SECONDARY outcome

Timeframe: Transplant through Week 52 Post-Transplant

Population: Intent-to-treat population

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.

Outcome measures

Measure	Investigational n=22 Participants 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.	Control n=21 Participants 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.
Count of Participants With an Infectious Disease Serious Adverse Event(s) Requiring Hospitalization or Systemic Therapy	11 Participants	11 Participants

SECONDARY outcome

Timeframe: Transplant through Week 52 Post-Transplant

Population: Intent-to-treat population

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.

Outcome measures

Measure	Investigational n=22 Participants 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.	Control n=21 Participants 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.
Count of Participant Diagnosed With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia As Adverse Events BK Viremia	8 Count of Participants	3 Count of Participants
Count of Participant Diagnosed With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia As Adverse Events CMV Viremia	5 Count of Participants	3 Count of Participants

SECONDARY outcome

Timeframe: Transplant through Week 52 Post-Transplant

Population: Intent-to-treat population

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.

Outcome measures

Measure	Investigational n=22 Participants 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.	Control n=21 Participants 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.
Count of Participants Diagnosed With Epstein-Barr Virus (EBV) Infection as an Adverse Event	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Transplant through Week 52 Post-Transplant

Population: Intent-to-treat population

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.

Outcome measures

Measure	Investigational n=22 Participants 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.	Control n=21 Participants 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.
Count of Participants Diagnosed With Malignancy as an Adverse Event	0 Participants	0 Participants

Adverse Events

Investigational

Serious events: 20 serious events

Other events: 20 other events

Deaths: 1 deaths

Control

Serious events: 19 serious events

Other events: 19 other events

Deaths: 0 deaths

Enrolled, Not Randomized

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Investigational n=22 participants at risk 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.	Control n=21 participants at risk 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.	Enrolled, Not Randomized n=3 participants at risk Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
Blood and lymphatic system disorders Anaemia	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Blood and lymphatic system disorders Febrile neutropenia	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Cardiac disorders Acute myocardial infarction	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Cardiac disorders Pulseless electrical activity	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Gastrointestinal disorders Abdominal pain	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Gastrointestinal disorders Abdominal pain lower	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Gastrointestinal disorders Ascites	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Gastrointestinal disorders Constipation	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Gastrointestinal disorders Diarrhoea	9.1% 2/22 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Gastrointestinal disorders Enterocolitis haemorrhagic	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Gastrointestinal disorders Gastrointestinal haemorrhage	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Gastrointestinal disorders Gastrooesophageal reflux disease	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Gastrointestinal disorders Ileus	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	9.5% 2/21 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Gastrointestinal disorders Nausea	9.1% 2/22 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Gastrointestinal disorders Oesophagitis	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Gastrointestinal disorders Pancreatitis	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Gastrointestinal disorders Small intestinal obstruction	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Gastrointestinal disorders Volvulus of small bowel	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Gastrointestinal disorders Vomiting	9.1% 2/22 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
General disorders Pyrexia	9.1% 2/22 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Immune system disorders Kidney transplant rejection	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	14.3% 3/21 • Number of events 3 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Immune system disorders Pancreas transplant rejection	31.8% 7/22 • Number of events 7 • Transplantation until end of study (up to 76 weeks)	14.3% 3/21 • Number of events 4 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Immune system disorders Renal and pancreas transplant rejection	9.1% 2/22 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Bacteraemia	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Cellulitis	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Clostridial infection	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Cytomegalovirus viraemia	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Gangrene	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Gastroenteritis	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Haematoma infection	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Infection	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Influenza	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	9.5% 2/21 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Meningitis viral	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Oesophageal candidiasis	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Pancreas infection	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Pancreatic abscess	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Parvovirus infection	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Pneumocystis jiroveci pneumonia	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Pneumonia	4.5% 1/22 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Pyelonephritis	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	9.5% 2/21 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Sepsis	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Urinary tract infection	13.6% 3/22 • Number of events 3 • Transplantation until end of study (up to 76 weeks)	19.0% 4/21 • Number of events 6 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Urinary tract infection bacterial	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Urosepsis	9.1% 2/22 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Viral upper respiratory tract infection	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Wound infection staphylococcal	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Injury, poisoning and procedural complications Anastomotic haemorrhage	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Injury, poisoning and procedural complications Chemical burn of skin	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Injury, poisoning and procedural complications Contusion	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Injury, poisoning and procedural complications Peripancreatic fluid collection	9.1% 2/22 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Injury, poisoning and procedural complications Post procedural haematoma	9.1% 2/22 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Injury, poisoning and procedural complications Renal transplant torsion	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Injury, poisoning and procedural complications Vascular pseudoaneurysm	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Investigations Blood creatinine increased	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Metabolism and nutrition disorders Dehydration	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	14.3% 3/21 • Number of events 3 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Metabolism and nutrition disorders Failure to thrive	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Nervous system disorders Diabetic autonomic neuropathy	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Renal and urinary disorders Neurogenic bladder	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Renal and urinary disorders Renal tubular necrosis	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Renal and urinary disorders Ureteric stenosis	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Renal and urinary disorders Urinary retention	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Skin and subcutaneous tissue disorders Skin ulcer	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Vascular disorders Arteriovenous fistula	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Vascular disorders Orthostatic hypotension	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Vascular disorders Peripheral ischaemia	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)

Other adverse events

Measure	Investigational n=22 participants at risk 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.	Control n=21 participants at risk 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.	Enrolled, Not Randomized n=3 participants at risk Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
Blood and lymphatic system disorders Anaemia	27.3% 6/22 • Number of events 6 • Transplantation until end of study (up to 76 weeks)	47.6% 10/21 • Number of events 11 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Blood and lymphatic system disorders Leukocytosis	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	9.5% 2/21 • Number of events 4 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Blood and lymphatic system disorders Leukopenia	27.3% 6/22 • Number of events 7 • Transplantation until end of study (up to 76 weeks)	14.3% 3/21 • Number of events 6 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Blood and lymphatic system disorders Thrombocytopenia	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	23.8% 5/21 • Number of events 5 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	9.5% 2/21 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations BK virus infection	36.4% 8/22 • Number of events 8 • Transplantation until end of study (up to 76 weeks)	14.3% 3/21 • Number of events 3 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Clostridial infection	9.1% 2/22 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	14.3% 3/21 • Number of events 4 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Cytomegalovirus infection	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	9.5% 2/21 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Cytomegalovirus viraemia	13.6% 3/22 • Number of events 6 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Oesophageal candidiasis	9.1% 2/22 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	4.8% 1/21 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Infections and infestations Urinary tract infection	36.4% 8/22 • Number of events 12 • Transplantation until end of study (up to 76 weeks)	14.3% 3/21 • Number of events 4 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	14.3% 3/21 • Number of events 3 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Investigations Amylase increased	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	9.5% 2/21 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Investigations Blood creatinine increased	13.6% 3/22 • Number of events 4 • Transplantation until end of study (up to 76 weeks)	14.3% 3/21 • Number of events 4 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Investigations Lipase increased	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	14.3% 3/21 • Number of events 3 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Investigations Weight increased	9.1% 2/22 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Metabolism and nutrition disorders Dehydration	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	9.5% 2/21 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Metabolism and nutrition disorders Hyperkalaemia	13.6% 3/22 • Number of events 3 • Transplantation until end of study (up to 76 weeks)	23.8% 5/21 • Number of events 6 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Metabolism and nutrition disorders Hypoalbuminaemia	4.5% 1/22 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	9.5% 2/21 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Metabolism and nutrition disorders Hypokalaemia	4.5% 1/22 • Number of events 1 • Transplantation until end of study (up to 76 weeks)	9.5% 2/21 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Renal and urinary disorders Renal failure acute	9.1% 2/22 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	14.3% 3/21 • Number of events 3 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Renal and urinary disorders Urinary retention	0.00% 0/22 • Transplantation until end of study (up to 76 weeks)	9.5% 2/21 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Skin and subcutaneous tissue disorders Skin ulcer	9.1% 2/22 • Number of events 2 • Transplantation until end of study (up to 76 weeks)	0.00% 0/21 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)
Vascular disorders Hypotension	9.1% 2/22 • Number of events 3 • Transplantation until end of study (up to 76 weeks)	9.5% 2/21 • Number of events 3 • Transplantation until end of study (up to 76 weeks)	0.00% 0/3 • Transplantation until end of study (up to 76 weeks)

Additional Information

Director, Clinical Research Operations Program

DAIT/NIAID

Phone: 301-594-7669

Email: DAITClinicalTrialsGov@niaid.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place