Trial Outcomes & Findings for Open-Label Phase 2 Trial of a Steroid-Free, CNI-Free, Belatacept-Based Immunosuppressive Regimen (NCT NCT01856257)

NCT ID: NCT01856257

Last Updated: 2020-12-17

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: 71 participants
• Primary outcome timeframe: Week 52
• Results posted on: 2020-12-17

Participant Flow

Three sites in the United States recruited and enrolled 71 participants into this trial.

Participant milestones

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Enrolled, Not Randomized Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
Overall Study STARTED	29	29	11	2
Overall Study COMPLETED	26	28	11	0
Overall Study NOT COMPLETED	3	1	0	2

Reasons for withdrawal

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Enrolled, Not Randomized Subjects who signed informed consent and were thus enrolled, but were not randomized to study treatment.
Overall Study Death	2	0	0	0
Overall Study Physician Decision	0	0	0	1
Overall Study Withdrawal by Subject	1	1	0	0
Overall Study Donor complication	0	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Total n=69 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	29 Participants n=7 Participants	11 Participants n=5 Participants	69 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	47.7 years STANDARD_DEVIATION 6.76 • n=5 Participants	44.5 years STANDARD_DEVIATION 10.45 • n=7 Participants	44.6 years STANDARD_DEVIATION 9.63 • n=5 Participants	45.9 years STANDARD_DEVIATION 8.93 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	21 Participants n=4 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	21 Participants n=7 Participants	7 Participants n=5 Participants	48 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	25 Participants n=7 Participants	9 Participants n=5 Participants	60 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	13 Participants n=7 Participants	5 Participants n=5 Participants	34 Participants n=4 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	11 Participants n=7 Participants	4 Participants n=5 Participants	24 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Region of Enrollment United States	29 participants n=5 Participants	29 participants n=7 Participants	11 participants n=5 Participants	69 participants n=4 Participants

PRIMARY outcome

Timeframe: Week 52

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	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=27 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=26 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Mean Estimated Glomerular Filtration Rate (eGFR) Calculated for Each Treatment Group Using the CKD-EPI Equation at Wk 52 Post-Transplant	61.5 mL/min/1.73m^2 Standard Deviation 23.3	63.0 mL/min/1.73m^2 Standard Deviation 17.4	59.2 mL/min/1.73m^2 Standard Deviation 19.9

SECONDARY outcome

Timeframe: Transplantation through Week 52

Population: Intent-to-treat population

Biopsy proven acute rejection definition: histologic evidence of a Banff grade of ≥1A per local pathologist.

Outcome measures

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Count of Participants With Biopsy Proven Acute Rejection By Wk 52 Post-Transplant	10 Participants	4 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 52

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	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Count of Participants With eGFR < 60 mL/Min/1.73 m^2 Measured by CKD-EPI at Wk 52 Post-Transplant	15 Participants	6 Participants	21 Participants

SECONDARY outcome

Timeframe: Week 52

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	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Count of Participants by CKD Stage at Wk 52 Stage 1	3 Participants	1 Participants	3 Participants
Count of Participants by CKD Stage at Wk 52 Stage 2	11 Participants	4 Participants	5 Participants
Count of Participants by CKD Stage at Wk 52 Stage 3A	9 Participants	6 Participants	11 Participants
Count of Participants by CKD Stage at Wk 52 Stage 3B	2 Participants	0 Participants	6 Participants
Count of Participants by CKD Stage at Wk 52 Stage 4	1 Participants	0 Participants	1 Participants
Count of Participants by CKD Stage at Wk 52 Stage 5	3 Participants	0 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 52

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	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Count of Participants With Defined CKD Stage 4 or 5 at Wk 52 Post-Transplant	4 Participants	0 Participants	4 Participants

SECONDARY outcome

Timeframe: Week 52

Population: Intent-to-treat population with available data

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	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=27 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=26 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Mean Calculated eGFR Using MDRD 4 Variable Model at Wk 52 Post-Transplant	57.0 mL/min/1.73m^2 Standard Deviation 20.7	58.2 mL/min/1.73m^2 Standard Deviation 14.4	56.1 mL/min/1.73m^2 Standard Deviation 18.5

SECONDARY outcome

Timeframe: Day 28 through Week 52 Post-Transplant

Population: Intent-to-treat population with available data

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	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=28 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
The Slope of eGFR by CKD-EPI Over Time Based on Serum Creatinine Post-Transplant	1.3 eGFR change over time (by month) Standard Deviation 2.6	0.8 eGFR change over time (by month) Standard Deviation 1.4	0.3 eGFR change over time (by month) Standard Deviation 4.1

SECONDARY outcome

Timeframe: Transplantation through Week 52

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	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Count of Participants With Delayed Graft Function at Wk 52 Post-Transplant	9 Participants	0 Participants	6 Participants

SECONDARY outcome

Timeframe: Transplantation through Week 52

Population: Intent-to-treat population

Acute cellular rejection occurs when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade equal to or greater than IA by Banff 2007 criteria as determined by local pathology.

Outcome measures

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Count of Participants With Acute Cellular Rejection Grade ≥ IA Defined by Banff 2007 Criteria By Wk 52 Post-Transplant	10 Participants	4 Participants	1 Participants

SECONDARY outcome

Timeframe: Transplantation through Week 52

Population: Intent-to-treat population

Acute cellular rejection occurs when lesions at the site of the graft characteristically are infiltrated with large numbers of lymphocytes and macrophages that cause tissue damage. Acute cellular rejection for this endpoint is defined as a grade equal to or greater than IA by Banff 2007 criteria as determined by local pathology. Severity is graded as IA, IB, IIA, IIB, or III, with IA being the mildest form of cellular rejection and III being the most severe form of cellular rejection. Originally it was 2 endpoints but all participants' highest grade was also their first grade so only reporting their first grade.

Outcome measures

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant IA	3 Participants	2 Participants	0 Participants
Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant IB	1 Participants	2 Participants	1 Participants
Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant IIA	4 Participants	0 Participants	0 Participants
Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant IIB	0 Participants	0 Participants	0 Participants
Count of Participants by Severity of First Acute Cellular Rejection by Wk 52 Post-Transplant III	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Transplantation through Week 52

Population: Intent-to-treat population

Antibody mediated rejection is defined by diffusely positive staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury and was determined by local pathology.

Outcome measures

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Count of Participants With Antibody Mediated Rejection by Wk 52 Post-Transplant	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Transplantation through Week 52

Population: Intent-to-treat population

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

• ACR= Acute T-Cell Mediated rejection
• AMR= Acute Antibody-mediated rejection
• Chr. AMR=Chronic Antibody Mediated Rejection
• Gd.=Grade
• IFTA=Interstitial Fibrosis and Tubular Atrophy

Outcome measures

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies Borderline	5 Biopsy	0 Biopsy	3 Biopsy
Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies Borderline, AMR-Gd. I (ATN-Like)	0 Biopsy	0 Biopsy	1 Biopsy
Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies Borderline, AMR-Gd.I (ATN-Like), Chr.AMR, IFTA-Gd1	0 Biopsy	0 Biopsy	1 Biopsy
Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies Borderline, AMR-Gd. I (ATN-Like), IFTA-Gd. I	1 Biopsy	0 Biopsy	0 Biopsy
Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies Borderline, Chr.AMR, IFTA-Gd. I	0 Biopsy	0 Biopsy	1 Biopsy
Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies Borderline, IFTA-Gd. I	2 Biopsy	1 Biopsy	1 Biopsy
Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies Borderline, IFTA- Gd. II	1 Biopsy	0 Biopsy	2 Biopsy
Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies ACR-Gd. IA	4 Biopsy	2 Biopsy	0 Biopsy
Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies ACR-Gd. IA, IFTA-Gd. I	1 Biopsy	0 Biopsy	0 Biopsy
Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies ACR-Gd. IA, IFTA-Gd. II	0 Biopsy	0 Biopsy	1 Biopsy
Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies ACR-Gd. IB	0 Biopsy	0 Biopsy	1 Biopsy
Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies ACR-Gd. IB, IFTA-Gd. I	1 Biopsy	1 Biopsy	0 Biopsy
Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies ACR-Gd. IB, IFTA-Gd. II	0 Biopsy	1 Biopsy	0 Biopsy
Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies ACR-Gd. IB, IFTA-Gd. III	1 Biopsy	0 Biopsy	0 Biopsy
Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies ACR-Gd. IIA	2 Biopsy	0 Biopsy	0 Biopsy
Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies ACR-Gd. IIA, IFTA-Gd. I	2 Biopsy	0 Biopsy	0 Biopsy
Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies ACR-Gd. III	2 Biopsy	0 Biopsy	0 Biopsy
Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies AMR-Gd. II (Capillary/Glomerular)	0 Biopsy	0 Biopsy	1 Biopsy
Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies IFTA-Gd. I	5 Biopsy	1 Biopsy	4 Biopsy
Type of Rejection Classified by Pathologist - For Cause Kidney Biopsies IFTA-Gd. II	2 Biopsy	0 Biopsy	1 Biopsy

SECONDARY outcome

Timeframe: Transplantation through Week 52

Population: Intent-to-treat population

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

ATG=Thymoglobulin

Outcome measures

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Type of Treatment for Detected Graft Rejection Prednisone	2 Biopsy	0 Biopsy	0 Biopsy
Type of Treatment for Detected Graft Rejection ATG	1 Biopsy	0 Biopsy	0 Biopsy
Type of Treatment for Detected Graft Rejection ATG, Pulse Steroids	5 Biopsy	2 Biopsy	0 Biopsy
Type of Treatment for Detected Graft Rejection ATG, Pulse Steroids, Prograf	1 Biopsy	0 Biopsy	0 Biopsy
Type of Treatment for Detected Graft Rejection Antibiotic	0 Biopsy	0 Biopsy	1 Biopsy
Type of Treatment for Detected Graft Rejection Plasmapheresis	0 Biopsy	0 Biopsy	1 Biopsy
Type of Treatment for Detected Graft Rejection Plasmapheresis, Oral Steroids	0 Biopsy	0 Biopsy	1 Biopsy
Type of Treatment for Detected Graft Rejection Pulse Steroids	9 Biopsy	3 Biopsy	6 Biopsy
Type of Treatment for Detected Graft Rejection Pulse Steroids, Leflunomide	1 Biopsy	0 Biopsy	0 Biopsy
Type of Treatment for Detected Graft Rejection Pulse Steroids, Plasmapheresis, Eculizumab	0 Biopsy	0 Biopsy	1 Biopsy

SECONDARY outcome

Timeframe: Week 52

Population: No analysis due to no available data. Data were not reported from the central laboratory and, therefore, unable to be summarized.

The presence of antibodies reactive to Histocompatibility Antigen (HLA) molecules expressed on the renal allograft have been associated with both acute and chronic injury to the transplanted kidney. The development of de novo anti donor HLA antibodies may mean a person is more likely to reject the graft.

No data available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Transplantation through Week 52

Population: Intent-to-treat population with available data

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

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

Outcome measures

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Count of Participants With Either New Onset Diabetes After Transplant (NODAT) or Impaired Fasting Glucose (IFG) at Week 52 Post-Transplant -Based on Criteria Specified by the ADA and WHO New onset diabetes during first 52 weeks	1 Participants	0 Participants	1 Participants
Count of Participants With Either New Onset Diabetes After Transplant (NODAT) or Impaired Fasting Glucose (IFG) at Week 52 Post-Transplant -Based on Criteria Specified by the ADA and WHO Impaired fasting glucose at week 52	0 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 14 through week 52

Population: Intent-to-treat population with available data

Treated diabetes is defined as receipt of any oral medication or insulin for the treatment of diabetes for >14 days.

Outcome measures

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=28 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=26 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Count of Participants With Treated Diabetes Between Day 14 and Wk 52 Post-Transplant	2 Participants	0 Participants	3 Participants

SECONDARY outcome

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

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	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=28 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=26 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Hemoglobin A1c (HbA1c) Measurements Over Time Baseline	5.7 percentage Standard Deviation 1.1	5.9 percentage Standard Deviation 0.8	5.7 percentage Standard Deviation 1.3
Hemoglobin A1c (HbA1c) Measurements Over Time Day 28	5.6 percentage Standard Deviation 1.0	5.4 percentage Standard Deviation 1.1	5.4 percentage Standard Deviation 0.8
Hemoglobin A1c (HbA1c) Measurements Over Time Day 84	5.5 percentage Standard Deviation 1.1	5.4 percentage Standard Deviation 0.8	5.6 percentage Standard Deviation 1.1
Hemoglobin A1c (HbA1c) Measurements Over Time Week 28	6.0 percentage Standard Deviation 1.4	5.6 percentage Standard Deviation 0.8	6.2 percentage Standard Deviation 1.9
Hemoglobin A1c (HbA1c) Measurements Over Time Week 36	5.9 percentage Standard Deviation 1.2	5.5 percentage Standard Deviation 0.8	6.7 percentage Standard Deviation 2.6
Hemoglobin A1c (HbA1c) Measurements Over Time Week 52	6.7 percentage Standard Deviation 1.6	5.8 percentage Standard Deviation 1.3	7.8 percentage Standard Deviation 3.3

SECONDARY outcome

Timeframe: Week 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	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=18 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=3 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=26 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Standardized Blood Pressure Measurement at Wk 52 Post-Transplant Systolic BP at W52	133.7 mmHg Standard Deviation 14.7	132.0 mmHg Standard Deviation 8.7	135.0 mmHg Standard Deviation 18.9
Standardized Blood Pressure Measurement at Wk 52 Post-Transplant Diastolic BP at W52	79.1 mmHg Standard Deviation 10.2	75.7 mmHg Standard Deviation 13.1	77.7 mmHg Standard Deviation 10.9

SECONDARY outcome

Timeframe: Week 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 stroke and myocardial infarction.

Outcome measures

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=28 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=26 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Count of Participants With Use of Anti-hypertensive Medication at Wk 52 Post-Transplant	23 Participants	8 Participants	18 Participants

SECONDARY outcome

Timeframe: Baseline

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	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=26 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=7 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=22 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Fasting Lipid Profile at Baseline (Pre-Transplant) Total cholesterol	159.4 mg/dL Standard Deviation 45.0	167.6 mg/dL Standard Deviation 84.8	167.1 mg/dL Standard Deviation 37.5
Fasting Lipid Profile at Baseline (Pre-Transplant) Non-HDL	116.1 mg/dL Standard Deviation 45.7	123.4 mg/dL Standard Deviation 85.3	122.0 mg/dL Standard Deviation 35.1
Fasting Lipid Profile at Baseline (Pre-Transplant) LDL	83.1 mg/dL Standard Deviation 38.5	65.2 mg/dL Standard Deviation 15.3	91.1 mg/dL Standard Deviation 28.0
Fasting Lipid Profile at Baseline (Pre-Transplant) HDL	43.3 mg/dL Standard Deviation 13.0	44.1 mg/dL Standard Deviation 19.9	45.1 mg/dL Standard Deviation 11.8
Fasting Lipid Profile at Baseline (Pre-Transplant) Triglyceride	194.4 mg/dL Standard Deviation 171.1	227.1 mg/dL Standard Deviation 248.1	156.8 mg/dL Standard Deviation 103.6

SECONDARY outcome

Timeframe: Week 28

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	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=15 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=10 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=15 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Fasting Lipid Profile at Wk 28 Post-Transplant Total cholesterol	179.5 mg/dL Standard Deviation 44.4	167.3 mg/dL Standard Deviation 39.5	169.6 mg/dL Standard Deviation 38.6
Fasting Lipid Profile at Wk 28 Post-Transplant Non-HDL	133.5 mg/dL Standard Deviation 46.7	115.0 mg/dL Standard Deviation 38.0	119.6 mg/dL Standard Deviation 35.9
Fasting Lipid Profile at Wk 28 Post-Transplant LDL	109.8 mg/dL Standard Deviation 43.0	82.7 mg/dL Standard Deviation 18.2	95.6 mg/dL Standard Deviation 31.4
Fasting Lipid Profile at Wk 28 Post-Transplant HDL	46.0 mg/dL Standard Deviation 18.6	52.3 mg/dL Standard Deviation 27.5	51.0 mg/dL Standard Deviation 14.5
Fasting Lipid Profile at Wk 28 Post-Transplant Triglyceride	153.3 mg/dL Standard Deviation 93.0	166.6 mg/dL Standard Deviation 128.9	126.4 mg/dL Standard Deviation 51.0

SECONDARY outcome

Timeframe: Week 52

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	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=9 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=8 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=8 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Fasting Lipid Profile at Wk 52 Post-Transplant LDL	86.3 mg/dL Standard Deviation 50.6	94.6 mg/dL Standard Deviation 46.4	102.9 mg/dL Standard Deviation 17.7
Fasting Lipid Profile at Wk 52 Post-Transplant HDL	42.4 mg/dL Standard Deviation 15.6	44.0 mg/dL Standard Deviation 14.9	48.5 mg/dL Standard Deviation 11.3
Fasting Lipid Profile at Wk 52 Post-Transplant Total cholesterol	163.7 mg/dL Standard Deviation 38.8	174.8 mg/dL Standard Deviation 54.7	177.1 mg/dL Standard Deviation 25.6
Fasting Lipid Profile at Wk 52 Post-Transplant Triglyceride	170.0 mg/dL Standard Deviation 118.6	182.8 mg/dL Standard Deviation 84.2	125.8 mg/dL Standard Deviation 93.0
Fasting Lipid Profile at Wk 52 Post-Transplant Non-HDL	121.2 mg/dL Standard Deviation 32.0	130.8 mg/dL Standard Deviation 45.6	128.6 mg/dL Standard Deviation 30.6

SECONDARY outcome

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

Population: Intent-to-treat population with available data

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

Outcome measures

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant Baseline	7 Participants	3 Participants	13 Participants
Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant Week 28	9 Participants	4 Participants	8 Participants
Count of Participants With Use of Lipid Lowering Medications at Baseline and Wk 28 and Wk 52 Post-Transplant Week 52	9 Participants	5 Participants	9 Participants

SECONDARY outcome

Timeframe: Day 28, Day 84, Week 28, Week 36, and Week 52

Population: Intent-to-treat population with available data

This is a measure of the total number of pills a participant was prescribed on a given day

Outcome measures

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=28 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=28 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Total Daily Prescribed Pill Count Day 28	18.9 pills per day Standard Deviation 7.5	23.5 pills per day Standard Deviation 8.9	25.8 pills per day Standard Deviation 9.9
Total Daily Prescribed Pill Count Day 84	17.2 pills per day Standard Deviation 6.3	21.0 pills per day Standard Deviation 7.0	22.2 pills per day Standard Deviation 6.3
Total Daily Prescribed Pill Count Week 28	15.5 pills per day Standard Deviation 6.0	16.6 pills per day Standard Deviation 8.1	19.7 pills per day Standard Deviation 7.2
Total Daily Prescribed Pill Count Week 36	15.4 pills per day Standard Deviation 4.8	13.9 pills per day Standard Deviation 5.9	19.1 pills per day Standard Deviation 8.0
Total Daily Prescribed Pill Count Week 52	15.7 pills per day Standard Deviation 5.4	13.7 pills per day Standard Deviation 5.1	24.4 pills per day Standard Deviation 11.8

SECONDARY outcome

Timeframe: Transplantation through Week 52

Population: Intent-to-treat population

This measure counts deaths and graft loss occurring at any point post transplantation. Graft loss is defined as 90 days of dialysis dependency.

Outcome measures

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Count of Participant Deaths or Graft Loss by Wk 52 Post-Transplant	0 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Transplantation through Week 52

Population: Intent-to-treat population

The number of participants who were treated by their local physician for any type of rejection including, but not limited to cellular rejection and antibody- mediated rejection of the transplanted kidney regardless of the presence of a biopsy.

Outcome measures

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Count of Participants With Graft Rejection by Wk 52 Post-Transplant	14 Participants	4 Participants	7 Participants

SECONDARY outcome

Timeframe: Enrollment through Week 52

Population: Intent-to-treat population

Adverse events were collected systematically from enrollment through Wk 52, the last study visit. Provided are numbers of participants with ≥ 1 adverse event (serious or non-serious adverse events) by treatment arm.

Outcome measures

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Count of Participants Experiencing ≥ 1 Adverse Event (AEs) or Serious Adverse Events (SAEs) by Wk 52 Serious Adverse Events	21 Participants	6 Participants	19 Participants
Count of Participants Experiencing ≥ 1 Adverse Event (AEs) or Serious Adverse Events (SAEs) by Wk 52 Adverse Events	28 Participants	9 Participants	21 Participants

SECONDARY outcome

Timeframe: Transplantation through Week 52

Population: Intent-to-treat population

Infections of certain types (i.e., excluding those identified in the protocol as occurring commonly in this study population) were required to be reported as a serious adverse event if they required either inpatient hospitalization or prolongation of a current hospitalization.

Outcome measures

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Count of Participants With Infections Requiring Hospitalization or Systemic Therapy by Wk 52 Post-Transplant	8 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Transplantation through Week 52

Population: Intent-to-treat population

Viral infections following renal transplantation is significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss. Specific viruses were monitored during the study, using participant blood samples. Displayed are counts of participants who experienced BKV and CMV viremia as adverse events by treatment arm.

Outcome measures

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Count of Participants With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia (Local Center Monitoring) as Adverse Events by Wk 52 Post-Transplant BKV	4 Participants	1 Participants	0 Participants
Count of Participants With BK Polyoma Virus (BKV) and Cytomegalovirus (CMV) Viremia (Local Center Monitoring) as Adverse Events by Wk 52 Post-Transplant CMV	6 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Transplantation through Week 52

Population: Intent-to-treat population

Viral infections following renal transplantation, including but not limited to EBV infection, is a significant source of recipient morbidity and mortality, and a significant cause of allograft dysfunction and loss.

Outcome measures

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Count of Participants With Epstein-Barr Virus (EBV) Infection as Reported on the Case Report Form as Adverse Events	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 24 Hours of transplant procedure

Population: Intent-to-treat population

Temperature of >39 degrees Celsius (e.g., 102.2 degrees Fahrenheit) would be an indication of fever most often in response to an infection or illness. Systolic blood pressure <90mm Hg would be an indication of low blood pressure.

Outcome measures

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 Participants Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 Participants Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.
Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90 mmHg Within 24 Hours of Onset of Transplant Procedure Fever >39 Celsius	0 Participants	0 Participants	0 Participants
Count of Participants With Fever > 39 Degrees Celsius and Blood Pressure < 90 mmHg Within 24 Hours of Onset of Transplant Procedure Systolic BP < 90 mmHg	0 Participants	0 Participants	0 Participants

Adverse Events

Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac

Serious events: 19 serious events

Other events: 15 other events

Deaths: 2 deaths

Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept

Serious events: 21 serious events

Other events: 24 other events

Deaths: 0 deaths

Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept

Serious events: 6 serious events

Other events: 7 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	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 participants at risk Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 participants at risk Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 participants at risk Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Enrolled, Not Randomized n=2 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	0.00% 0/29 • Enrollment through end of study (up to Week 52)	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Blood and lymphatic system disorders Haemolytic uraemic syndrome	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Cardiac disorders Atrial fibrillation	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Gastrointestinal disorders Abdominal pain lower	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Gastrointestinal disorders Diarrhoea	0.00% 0/29 • Enrollment through end of study (up to Week 52)	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Gastrointestinal disorders Duodenal ulcer haemorrhage	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Gastrointestinal disorders Ileus	0.00% 0/29 • Enrollment through end of study (up to Week 52)	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Gastrointestinal disorders Intra-abdominal haemorrhage	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Gastrointestinal disorders Nausea	6.9% 2/29 • Number of events 2 • Enrollment through end of study (up to Week 52)	3.4% 1/29 • Number of events 2 • Enrollment through end of study (up to Week 52)	9.1% 1/11 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Gastrointestinal disorders Pancreatitis	0.00% 0/29 • Enrollment through end of study (up to Week 52)	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Gastrointestinal disorders Retroperitoneal haematoma	0.00% 0/29 • Enrollment through end of study (up to Week 52)	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Gastrointestinal disorders Vomiting	6.9% 2/29 • Number of events 2 • Enrollment through end of study (up to Week 52)	3.4% 1/29 • Number of events 2 • Enrollment through end of study (up to Week 52)	9.1% 1/11 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
General disorders Chest pain	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
General disorders Pyrexia	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Hepatobiliary disorders Bile duct stone	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Immune system disorders Kidney transplant rejection	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	9.1% 1/11 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Immune system disorders Transplant rejection	6.9% 2/29 • Number of events 2 • Enrollment through end of study (up to Week 52)	27.6% 8/29 • Number of events 10 • Enrollment through end of study (up to Week 52)	18.2% 2/11 • Number of events 2 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Infections and infestations Bacteraemia	0.00% 0/29 • Enrollment through end of study (up to Week 52)	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Infections and infestations Clostridium difficile colitis	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Infections and infestations Cytomegalovirus infection	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	9.1% 1/11 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Infections and infestations Cytomegalovirus viraemia	0.00% 0/29 • Enrollment through end of study (up to Week 52)	13.8% 4/29 • Number of events 4 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Infections and infestations Gastroenteritis	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Infections and infestations Gastroenteritis viral	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Infections and infestations Peritonitis bacterial	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Infections and infestations Pneumonia cytomegaloviral	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Infections and infestations Polyomavirus-associated nephropathy	0.00% 0/29 • Enrollment through end of study (up to Week 52)	6.9% 2/29 • Number of events 2 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Infections and infestations Pyelonephritis	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Infections and infestations Septic shock	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Infections and infestations Urinary tract infection	17.2% 5/29 • Number of events 5 • Enrollment through end of study (up to Week 52)	13.8% 4/29 • Number of events 5 • Enrollment through end of study (up to Week 52)	9.1% 1/11 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Infections and infestations Zygomycosis	0.00% 0/29 • Enrollment through end of study (up to Week 52)	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	0.00% 0/29 • Enrollment through end of study (up to Week 52)	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Injury, poisoning and procedural complications Complications of transplanted kidney	6.9% 2/29 • Number of events 2 • Enrollment through end of study (up to Week 52)	13.8% 4/29 • Number of events 4 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/29 • Enrollment through end of study (up to Week 52)	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/29 • Enrollment through end of study (up to Week 52)	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Injury, poisoning and procedural complications Perinephric collection	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/29 • Enrollment through end of study (up to Week 52)	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Metabolism and nutrition disorders Fluid overload	0.00% 0/29 • Enrollment through end of study (up to Week 52)	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Metabolism and nutrition disorders Hyperkalaemia	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Renal and urinary disorders Glomerulonephritis minimal lesion	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Renal and urinary disorders Haematuria	0.00% 0/29 • Enrollment through end of study (up to Week 52)	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Renal and urinary disorders Hydronephrosis	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Renal and urinary disorders Renal artery dissection	0.00% 0/29 • Enrollment through end of study (up to Week 52)	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Renal and urinary disorders Renal failure acute	13.8% 4/29 • Number of events 4 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Renal and urinary disorders Renal tubular necrosis	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Reproductive system and breast disorders Oedema genital	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Vascular disorders Deep vein thrombosis	0.00% 0/29 • Enrollment through end of study (up to Week 52)	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Vascular disorders Hypertensive crisis	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Vascular disorders Orthostatic hypotension	0.00% 0/29 • Enrollment through end of study (up to Week 52)	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)

Other adverse events

Measure	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Tac n=29 participants at risk Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. The site investigator determined the starting dose. The first tacrolimus (tac) dosing was administered on the day of transplant or day 1 and was adjusted to achieve a target trough of 8-12 ng/ml during the first 24 weeks post-transplant and 5-8 ng/mL thereafter.	Induction:MEDROL+Thymoglobulin, Maintenance:MMF+Belatacept n=29 participants at risk Induction: Methylprednisolone (MEDROL) was administered at a dose of 500mg on the day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Thymoglobulin via intravenous infusion was administered at a target dose of 6 mg/kg over 3 to 4 days. Maintenance: Belatacept (NULOJIX) was given at a dose of 10 mg/kg beginning 24 hours from the time of reperfusion, and then at days 5, 14, 28, 56 and 84. Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1.	Induction:MEDROL+Simulect+Tac, Maintenance:MMF+Belatacept n=11 participants at risk Induction: Methylprednisolone (MEDROL) was administered at 500mg on day of transplant, and tapered to 250 mg on day 1, 125 mg on day 2, 60 mg on day 3, 30 mg on day 4, and 0 mg on day 5. Basiliximab (Simulect) was administered in two 20 mg doses, within 2 hours prior to transplantation and on day 3. The site investigator determined the initial tacrolimus (tac) dose started on the day of transplant or day 1. Dosing was adjusted to achieve a target trough of 8-12 ng/ml during days 1-84, and then decreased by 1/3 at day 84 and by 1/3 at week 16. If trough levels were less than or equal to 3 ng/ml at week 20 then all tac was stopped. Otherwise, the dose was reduced by 1/2 and stopped at week 24. Maintenance: Mycophenolate Mofetil (MMF) or equivalent was administered at a target dose of 1000 mg PO or IV BID starting on the day of transplant or day 1. Belatacept (NULOJIX) was given at 10 mg/kg beginning 24 hours from the time of reperfusion, and at days 5, 14, 28, 56 and 84	Enrolled, Not Randomized n=2 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	24.1% 7/29 • Number of events 8 • Enrollment through end of study (up to Week 52)	17.2% 5/29 • Number of events 5 • Enrollment through end of study (up to Week 52)	27.3% 3/11 • Number of events 3 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Blood and lymphatic system disorders Eosinophilia	6.9% 2/29 • Number of events 2 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Blood and lymphatic system disorders Leukocytosis	10.3% 3/29 • Number of events 3 • Enrollment through end of study (up to Week 52)	6.9% 2/29 • Number of events 2 • Enrollment through end of study (up to Week 52)	9.1% 1/11 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Blood and lymphatic system disorders Leukopenia	13.8% 4/29 • Number of events 4 • Enrollment through end of study (up to Week 52)	10.3% 3/29 • Number of events 3 • Enrollment through end of study (up to Week 52)	9.1% 1/11 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Cardiac disorders Tachycardia	6.9% 2/29 • Number of events 2 • Enrollment through end of study (up to Week 52)	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
General disorders Chest pain	6.9% 2/29 • Number of events 2 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Immune system disorders Transplant rejection	3.4% 1/29 • Number of events 2 • Enrollment through end of study (up to Week 52)	13.8% 4/29 • Number of events 6 • Enrollment through end of study (up to Week 52)	9.1% 1/11 • Number of events 2 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Infections and infestations Urinary tract infection	3.4% 1/29 • Number of events 3 • Enrollment through end of study (up to Week 52)	27.6% 8/29 • Number of events 9 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Injury, poisoning and procedural complications Complications of transplanted kidney	10.3% 3/29 • Number of events 3 • Enrollment through end of study (up to Week 52)	27.6% 8/29 • Number of events 8 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Investigations Alanine aminotransferase increased	0.00% 0/29 • Enrollment through end of study (up to Week 52)	6.9% 2/29 • Number of events 2 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Investigations White blood cell count decreased	13.8% 4/29 • Number of events 4 • Enrollment through end of study (up to Week 52)	10.3% 3/29 • Number of events 4 • Enrollment through end of study (up to Week 52)	9.1% 1/11 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Metabolism and nutrition disorders Fluid overload	6.9% 2/29 • Number of events 2 • Enrollment through end of study (up to Week 52)	0.00% 0/29 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Metabolism and nutrition disorders Hyperkalaemia	17.2% 5/29 • Number of events 7 • Enrollment through end of study (up to Week 52)	13.8% 4/29 • Number of events 5 • Enrollment through end of study (up to Week 52)	9.1% 1/11 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/29 • Enrollment through end of study (up to Week 52)	6.9% 2/29 • Number of events 2 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Metabolism and nutrition disorders Hypophosphataemia	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	10.3% 3/29 • Number of events 3 • Enrollment through end of study (up to Week 52)	9.1% 1/11 • Number of events 1 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)
Vascular disorders Hypertension	3.4% 1/29 • Number of events 1 • Enrollment through end of study (up to Week 52)	6.9% 2/29 • Number of events 2 • Enrollment through end of study (up to Week 52)	0.00% 0/11 • Enrollment through end of study (up to Week 52)	0.00% 0/2 • Enrollment through end of study (up to Week 52)

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