Trial Outcomes & Findings for Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT) (NCT NCT00256750)

NCT ID: NCT00256750

Last Updated: 2016-08-19

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

738 participants

Primary outcome timeframe

Day 1 to Month 12

Results posted on

2016-08-19

Participant Flow

738 participants enrolled, 686 randomized. Reasons for non-randomization include 5 participants withdrew consent, 1 lost to follow-up, 34 no longer met study criteria, and 12 for other non-listed reasons. 666 participants randomized, but not transplanted. 20 not transplanted; 10, 4, 6 in the CsA, Belatacept LI, Belatacept MI, respectively.

Participant milestones

Participant milestones
Measure	Cyclosporine Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Transplanted Pre-Treatment STARTED	221	226	219
Transplanted Pre-Treatment COMPLETED	215	226	219
Transplanted Pre-Treatment NOT COMPLETED	6	0	0
Post-Transplant Treated (12 Months) STARTED	215	226	219
Post-Transplant Treated (12 Months) COMPLETED	174	183	173
Post-Transplant Treated (12 Months) NOT COMPLETED	41	43	46
Post-Transplant Treated (24 Months) STARTED	174	183	173
Post-Transplant Treated (24 Months) COMPLETED	153	176	164
Post-Transplant Treated (24 Months) NOT COMPLETED	21	7	9
Post-Transplant Treated (36 Months) STARTED	153	176	164
Post-Transplant Treated (36 Months) COMPLETED	143	170	158
Post-Transplant Treated (36 Months) NOT COMPLETED	10	6	6
Long Term Extension (LTE; 84 Months) STARTED	136	166	155
Long Term Extension (LTE; 84 Months) COMPLETED	89	136	127
Long Term Extension (LTE; 84 Months) NOT COMPLETED	47	30	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Cyclosporine Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Transplanted Pre-Treatment Withdrawal by Subject	3	0	0
Transplanted Pre-Treatment Other	2	0	0
Transplanted Pre-Treatment Death	1	0	0
Post-Transplant Treated (12 Months) Adverse Event	20	12	8
Post-Transplant Treated (12 Months) Death	3	2	4
Post-Transplant Treated (12 Months) Lack of Efficacy	10	22	27
Post-Transplant Treated (12 Months) Lost to Follow-up	1	0	0
Post-Transplant Treated (12 Months) Other	5	4	2
Post-Transplant Treated (12 Months) Withdrawal by Subject	0	3	5
Post-Transplant Treated (12 Months) Protocol Violation	2	0	0
Post-Transplant Treated (24 Months) Adverse Event	7	3	6
Post-Transplant Treated (24 Months) Withdrawal by Subject	5	1	0
Post-Transplant Treated (24 Months) Death	3	0	0
Post-Transplant Treated (24 Months) Lack of Efficacy	4	3	2
Post-Transplant Treated (24 Months) Other	2	0	1
Post-Transplant Treated (36 Months) Adverse Event	5	1	2
Post-Transplant Treated (36 Months) Withdrawal by Subject	1	0	1
Post-Transplant Treated (36 Months) Death	0	2	1
Post-Transplant Treated (36 Months) Subject no longer meets study criteria	0	0	1
Post-Transplant Treated (36 Months) Lack of Efficacy	4	1	0
Post-Transplant Treated (36 Months) Protocol Violation	0	1	0
Post-Transplant Treated (36 Months) Other	0	1	1
Long Term Extension (LTE; 84 Months) Adverse Event	13	11	14
Long Term Extension (LTE; 84 Months) Withdrawal by Subject	5	4	1
Long Term Extension (LTE; 84 Months) Lost to Follow-up	4	1	1
Long Term Extension (LTE; 84 Months) Death	9	4	4
Long Term Extension (LTE; 84 Months) Lack of Efficacy	6	3	0
Long Term Extension (LTE; 84 Months) Poor/Non-compliance	4	1	1
Long Term Extension (LTE; 84 Months) Pregnancy	0	1	2
Long Term Extension (LTE; 84 Months) Administrative Reason By Sponsor	1	1	0
Long Term Extension (LTE; 84 Months) Other	5	4	5

Baseline Characteristics

Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cyclosporine n=221 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=226 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=219 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Total n=666 Participants Total of all reporting groups
Age, Continuous	43.5 years STANDARD_DEVIATION 14.3 • n=5 Participants	42.6 years STANDARD_DEVIATION 13.4 • n=7 Participants	43.6 years STANDARD_DEVIATION 14.6 • n=5 Participants	43.2 years STANDARD_DEVIATION 14.1 • n=4 Participants
Age, Customized Between 18 and 45 years:	110 participants n=5 Participants	124 participants n=7 Participants	111 participants n=5 Participants	345 participants n=4 Participants
Age, Customized Between 46 and 65 years:	101 participants n=5 Participants	93 participants n=7 Participants	93 participants n=5 Participants	287 participants n=4 Participants
Age, Customized > 65 years:	10 participants n=5 Participants	9 participants n=7 Participants	15 participants n=5 Participants	34 participants n=4 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	80 Participants n=7 Participants	68 Participants n=5 Participants	204 Participants n=4 Participants
Sex: Female, Male Male	165 Participants n=5 Participants	146 Participants n=7 Participants	151 Participants n=5 Participants	462 Participants n=4 Participants
Previous Number of Transplant 0	208 participants n=5 Participants	218 participants n=7 Participants	210 participants n=5 Participants	636 participants n=4 Participants
Previous Number of Transplant 1	9 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants	19 participants n=4 Participants
Previous Number of Transplant 2	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Previous Number of Transplant Missing	4 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants	10 participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1 to Month 12

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population

Outcome measures

Outcome measures
Measure	Cyclosporine n=221 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=226 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=219 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants Surviving With a Functioning Graft by Month 12	92.8 percentage of participants Interval 89.3 to 96.2	96.5 percentage of participants Interval 94.1 to 98.9	95.4 percentage of participants Interval 92.7 to 98.2

PRIMARY outcome

Timeframe: Month 12; Month 3 to Month 12

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m\^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 mg/dL. A change in GFR of at least 10 mL/min/1.73 m\^2 was used as the approximate change in SCr of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3.

Outcome measures

Outcome measures
Measure	Cyclosporine n=213 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=214 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=209 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants With a Composite of Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12 or With a Decrease in mGFR Greater Than or Equal to 10 mL/Min/1.73m^2 From Month 3 to Month 12	77.9 percentage of participants Interval 72.4 to 83.5	54.2 percentage of participants Interval 47.5 to 60.9	55.0 percentage of participants Interval 48.3 to 61.8

PRIMARY outcome

Timeframe: Day 1 to Month 12

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population

Acute rejection was defined as a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence was defined if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. AR was defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted.

Outcome measures

Outcome measures
Measure	Cyclosporine n=221 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=226 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=219 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants Experiencing Acute Rejection (AR) Post-transplant by Month 12	7.2 percentage of participants Interval 3.8 to 10.7	17.3 percentage of participants Interval 12.3 to 22.2	21.9 percentage of participants Interval 16.4 to 27.4

SECONDARY outcome

Timeframe: Months 3, 12, 24

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m\^2.

Outcome measures

Outcome measures
Measure	Cyclosporine n=201 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=215 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=209 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Mean Value of the Measured Glomerular Filtration Rate (mGFR) Month 3 (n=201, 215, 209)	51.9 mL/min/1.73m^2 Standard Deviation 21.09	61.7 mL/min/1.73m^2 Standard Deviation 25.43	59.9 mL/min/1.73m^2 Standard Deviation 28.47
Mean Value of the Measured Glomerular Filtration Rate (mGFR) Month 12 (n=199, 206, 200)	50.4 mL/min/1.73m^2 Standard Deviation 18.71	63.4 mL/min/1.73m^2 Standard Deviation 27.66	65.0 mL/min/1.73m^2 Standard Deviation 30.02
Mean Value of the Measured Glomerular Filtration Rate (mGFR) Month 24 (n=185, 199, 192)	50.5 mL/min/1.73m^2 Standard Deviation 20.52	67.9 mL/min/1.73m^2 Standard Deviation 29.90	65.0 mL/min/1.73m^2 Standard Deviation 27.21

SECONDARY outcome

Timeframe: Month 12

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component; Any participant not meeting CAN criteria and who has no biopsy either prior to or post 12 months and no GFR assessment (either measured or calculated) available were excluded from the analyses.

Prevalence of CAN = if participant met any of the following conditions: a: CAN observed in a biopsy either prior to 12 months (including baseline biopsy) or first post 12 months biopsy; b: participant had graft loss during the first year post transplant; c: no biopsy was available post 12 months and CAN not observed in biopsies prior to 12 months, but the measured GFR from Month 3 to Month 12 decreased at least 10 mL/min/1.73m\^2; d: no biopsy available either prior to or post 12 months, and the measured GFR (incorporated missing data imputation) from Month 3 to Month 12 decreased at least 10 mL/min/1.73m\^2. CAN = All allograft biopsies evaluated for presence and severity of CAN by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Onset of CAN determined by the biopsy date when it was observed.

Outcome measures

Outcome measures
Measure	Cyclosporine n=219 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=226 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=219 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants With Prevalence of Chronic Allograft Nephropathy (CAN) at Month 12	32.4 percentage of participants Interval 26.2 to 38.6	23.9 percentage of participants Interval 18.3 to 29.5	18.3 percentage of participants Interval 13.1 to 23.4

SECONDARY outcome

Timeframe: Randomization to Month 84

Population: All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE)

Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.

Outcome measures

Outcome measures
Measure	Cyclosporine n=136 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=166 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=155 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84 Deaths	9 participants	7 participants	7 participants
Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84 SAEs	107 participants	113 participants	117 participants
Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84 Discontinued due to SAEs	5 participants	8 participants	6 participants
Number of Participants With Serious Adverse Events, Death, Discontinuation Due to Adverse Events by Month 84 Discontinued due to AEs	12 participants	11 participants	14 participants

SECONDARY outcome

Timeframe: Randomization to Month 84

Population: All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE)

Prospectively identified events of special interest which were a subset of all AEs, and were either SAEs or non-serious AEs, included the following categories: Serious Infections and Infestations, Thrombolic/embolic events, and Malignancy. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/ abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Time frame is from randomization to the event date, or to the last dose date+56, or to Month 84 (Day 2548), whichever is the earliest.

Outcome measures

Outcome measures
Measure	Cyclosporine n=136 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=166 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=155 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Number of Participants With Adverse Events of Special Interest by Month 84 Malignancies	22 participants	16 participants	20 participants
Number of Participants With Adverse Events of Special Interest by Month 84 Cytomegalovirus (CMV) Infections	19 participants	24 participants	20 participants
Number of Participants With Adverse Events of Special Interest by Month 84 BK Polyoma Virus Infections	6 participants	10 participants	15 participants
Number of Participants With Adverse Events of Special Interest by Month 84 Fungal Infections	42 participants	47 participants	55 participants
Number of Participants With Adverse Events of Special Interest by Month 84 Central Nervous System (CNS) Infections	0 participants	0 participants	1 participants
Number of Participants With Adverse Events of Special Interest by Month 84 Pulmonary edema or Congestive Heart Failure	12 participants	4 participants	5 participants
Number of Participants With Adverse Events of Special Interest by Month 84 Auto-immune Events	8 participants	8 participants	6 participants
Number of Participants With Adverse Events of Special Interest by Month 84 Herpes Virus Infections	29 participants	37 participants	37 participants
Number of Participants With Adverse Events of Special Interest by Month 84 Tuberculosis Infections	2 participants	1 participants	5 participants

SECONDARY outcome

Timeframe: Month 84

Population: All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population who continued on assigned therapy into the long-term extension phase (ITT-LTE).

Blood pressure was measured in millimeters of mercury (mmHg). Blood pressure was measured soon after the participant arrived and sat quietly at rest for 10 minutes. 3 consecutive seated blood pressure readings were made at least 1 minute apart.

Outcome measures

Outcome measures
Measure	Cyclosporine n=136 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=166 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=155 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Mean Blood Pressure at Month 84 Diastolic Blood Pressure (n=82, 125, 112)	78.6 mmHg Standard Deviation 11.03	75.8 mmHg Standard Deviation 10.56	75.1 mmHg Standard Deviation 10.15
Mean Blood Pressure at Month 84 Systolic Blood Pressure (n=82, 125, 112)	129.0 mmHg Standard Deviation 15.83	126.7 mmHg Standard Deviation 18.17	126.0 mmHg Standard Deviation 17.56

SECONDARY outcome

Timeframe: Baseline to Month 36

Population: All randomized, transplanted, and treated participants from the original intent-to-treat (ITT) population

Upper limit of normal (ULN). Units per Liter (U/L). Cells per microliter (c/µL). Grams per deciliter (g/dL). Milligrams per deciliter (mg/dL).Cells per Liter (c/L). Milliequivalents/Liter (mEq/L). Hemoglobin (low): \<8.0 g/dL; Platelet count: \<50\*10\^9 c/L; Leukocytes: \<2\*10\^3 c/µL; Alkaline phosphatase (ALP): \>5.0\*ULN U/L; Alanine aminotransferase (ALT): \>5.0\*ULN U/L; Asparate aminotransferase (AST): \>5.0\*ULN U/L; Bilirubin Total: \>3.0\*ULN mg/dL; Creatinine: \>3.0\*ULN mg/dL; Calcium Total: low if \<7.0 mg/dL or high if \>12.5 mg/dL; Bicarbonate: \<11.0 mEq/L; Potassium serum: low if \<3.0 mEq/L or high if \>6.0 mEq/L; Magnesium serum: low is \<0.8 mEq/L or high if \>2.46 mEq/L; Sodium serum: low if \<130.0 mEq/L or high if \>155.0 mEq/L; Phosphorus inorganic: \<2.0 mg/dL; Albumin: \<2 g/dL; Uric acid: \>10 mg/dL; Protein urine: \>=3+

Outcome measures

Outcome measures
Measure	Cyclosporine n=221 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=226 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=219 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Hemoglobin, low (n=213, 226, 219)	26 participants	25 participants	27 participants
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Platelet count, low (n=213, 226, 218)	0 participants	1 participants	0 participants
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Calcium total, high (n=214, 226, 219)	0 participants	1 participants	0 participants
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Leukocytes, low (n=213, 226, 219)	10 participants	5 participants	5 participants
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Alkaline phosphatase, high (n=214, 226, 219)	1 participants	4 participants	0 participants
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Bilirubin total, high (n=214, 226, 219)	1 participants	0 participants	0 participants
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Creatinine, high (n=213, 223, 219)	48 participants	50 participants	52 participants
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Calcium total, low (n=214, 226, 219)	7 participants	8 participants	4 participants
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Bicarbonate, low (n=214, 226, 219)	1 participants	0 participants	0 participants
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Potassium serum, high (n=213, 223, 219)	13 participants	9 participants	4 participants
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Magnessium serum, low (n=214, 225, 219)	1 participants	2 participants	1 participants
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Sodium serum, high (n=214, 226, 219)	0 participants	1 participants	0 participants
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Albumin, low (n=214, 226, 219)	0 participants	0 participants	0 participants
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Uric acid, high (n=214, 226, 219)	42 participants	7 participants	11 participants
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Protein in urine, high (n=213, 224, 217)	33 participants	30 participants	36 participants
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Alanine aminotransferase, high (n=214, 226, 219)	6 participants	6 participants	4 participants
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Aspartate aminotransferase, high (n=214, 226, 219)	2 participants	3 participants	3 participants
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Bicarbonate, high (n=214, 226, 219)	0 participants	0 participants	0 participants
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Potassium serum, low (n=213, 223, 219)	4 participants	13 participants	12 participants
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Magnessium serum, high (n=214, 225, 219)	9 participants	12 participants	14 participants
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Sodium serum, low (n=214, 226, 219)	21 participants	8 participants	9 participants
Number of Participants Meeting Marked Laboratory Abnormality Criteria Post-transplant by Month 36 Phosphorus inorganic, low (n=213, 224, 219)	75 participants	100 participants	112 participants

SECONDARY outcome

Timeframe: Randomization to Month 84

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population

Only participants who had non-missing test result for Class I or Class II anti-donor HLA antibodies were included in analysis and only participants who had at least one non-NA test result or finding were counted. This was a cumulative summary (excluding baseline) and once a participant was positive, that participant remained positive for the later time point. Acute rejection (AR) defined: a clinico-pathological event requiring clinical evidence and biopsy confirmation. Clinical evidence defined: if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. AR defined as allograft biopsies of Banff 97 classification Grade IA or greater (higher scores indicate more severe rejection). Evaluated by blinded central independent pathologist.

Outcome measures

Outcome measures
Measure	Cyclosporine n=215 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=226 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=219 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants With Development of Anti-Donor HLA Positive Antibodies by Month 84	11.6 percentage of participants Interval 7.34 to 15.91	3.1 percentage of participants Interval 0.84 to 5.36	1.4 percentage of participants Interval 0.28 to 3.95

SECONDARY outcome

Timeframe: Month 3 to Month 12; Month 3 to Month 24

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. Missing mGRF assessments were imputed to assess renal function. The overall imputation strategy involved a primary imputation method (linear extrapolation and quartile method) followed by 2 secondary imputation methods (regression method and graded quartile method) to assess the robustness of conclusions obtained from the application of the primary imputation method. All imputation methods entailed replacing a missing value with a value drawn from a plausible distribution incorporating theoretical and observed aspects of the data. GFR was measured as mL/min/1.73 m\^2.

Outcome measures

Outcome measures
Measure	Cyclosporine n=195 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=206 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=200 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Mean Change of the Measured Glomerular Filtration Rate (mGFR) From Month 3 to Month 12 and From Month 3 to Month 24 Baseline (Month 3) to Month 24 (n=184, 199, 192)	-2.0 mL/min/1.73m^2 Standard Deviation 25.23	5.3 mL/min/1.73m^2 Standard Deviation 33.03	4.2 mL/min/1.73m^2 Standard Deviation 30.96
Mean Change of the Measured Glomerular Filtration Rate (mGFR) From Month 3 to Month 12 and From Month 3 to Month 24 Baseline (Month 3) to Month 12 (n=195, 206, 200)	-1.7 mL/min/1.73m^2 Standard Deviation 21.58	1.2 mL/min/1.73m^2 Standard Deviation 30.43	4.4 mL/min/1.73m^2 Standard Deviation 31.10

SECONDARY outcome

Timeframe: Month 3 to Month 12

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A change in GFR of at least 10 mL/min/1.73 m\^2 was used as the approximate change in serum creatinine (SCr) of at least 0.3 mg/dL. The change component of the composite renal endpoint was assessed from Month 3 to Month 12, since post-transplant renal function is largely stable by Month 3. Month 3 = baseline

Outcome measures

Outcome measures
Measure	Cyclosporine n=213 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=214 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=209 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants With a Decrease in Measured Glomerular Filtration Rate (mGFR) Greater Than or Equal to 10mL/Min/1.73m^2 From Month 3 to Month 12	28.2 percentage of participants Interval 22.1 to 34.2	23.4 percentage of participants Interval 17.7 to 29.0	23.0 percentage of participants Interval 17.3 to 28.7

SECONDARY outcome

Timeframe: Month 12

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Measured glomerular filtration rate (mGFR) is the direct measurement of renal function and was assessed by measurement of the clearance of a true glomerular filtration marker (non-radiolabeled iothalamate) using a validated procedure. A GFR of 60 mL/min/1.73 m\^2 was used as the approximate equal of the threshold values of serum creatinine (SCr) of 1.5 milligrams per deciliter (mg/dL).

Outcome measures

Outcome measures
Measure	Cyclosporine n=213 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=214 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=209 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants With a Measured Glomerular Filtration Rate (mGFR) Less Than 60 mL/Min/1.73 m^2 at Month 12	67.6 percentage of participants Interval 61.3 to 73.9	43 percentage of participants Interval 36.4 to 49.6	43.5 percentage of participants Interval 36.8 to 50.3

SECONDARY outcome

Timeframe: Months 6, 12, 24, 36

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Calculated glomerular filtration rate (cGFR) was used to assess renal function (as measured by the estimated creatinine clearance) using the following modification of diet in renal disease (MDRD) formula: MDRD: GFR = 170 x \[SCr/0.95\]\^(-0.999) x \[Age\]\^(-0.176) x \[0.762 if participant is female\] x \[1.180 if participant is black\] x \[BUN\]\^(-0.170) x \[Alb\]\^(+0.318); Age in years; Alb = Albumin in g/dL; SCr = Serum creatinine in mg/dL; BUN = Blood urea nitrogen in mg/dL; cGFR = mL/min/1.73m2

Outcome measures

Outcome measures
Measure	Cyclosporine n=199 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=201 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=201 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation Month 6 (n=189, 185, 170)	48.8 mL/min/1.73 m^2 Standard Deviation 19.22	62.6 mL/min/1.73 m^2 Standard Deviation 20.41	62.4 mL/min/1.73 m^2 Standard Deviation 20.94
Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation Month 12 (n=199, 200, 201)	50.1 mL/min/1.73 m^2 Standard Deviation 21.06	65.4 mL/min/1.73 m^2 Standard Deviation 22.94	65.2 mL/min/1.73 m^2 Standard Deviation 23.51
Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation Month 24 (n=182, 201, 191)	47.9 mL/min/1.73 m^2 Standard Deviation 23.00	65.4 mL/min/1.73 m^2 Standard Deviation 25.22	65.5 mL/min/1.73 m^2 Standard Deviation 24.87
Mean Value of the Calculated Glomerular Filtration Rate (cGFR) With Imputation Month 36 (n=171, 190, 186)	44.4 mL/min/1.73 m^2 Standard Deviation 23.58	65.8 mL/min/1.73 m^2 Standard Deviation 27.00	65.2 mL/min/1.73 m^2 Standard Deviation 26.31

SECONDARY outcome

Timeframe: Month 6 to Month 12

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Outcome measures

Outcome measures
Measure	Cyclosporine n=166 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=169 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=160 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Mean Change in Calculated Glomerular Filtration Rate (cGFR) From Month 6 to Month 12	2.3 mL/Min/1.73 m^2 Standard Deviation 10.09	4.7 mL/Min/1.73 m^2 Standard Deviation 11.52	5.1 mL/Min/1.73 m^2 Standard Deviation 11.37

SECONDARY outcome

Timeframe: Week 4 post-transplantation to Month 36

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

The incidence of new onset diabetes mellitus defined as participants who developed diabetes mellitus after randomization and transplantation. Participants that did not have diabetes prior to randomization were determined to have new onset diabetes mellitus if (i) the participant received an anti-diabetic medication for a duration of at least 30 days or (ii) at least two fasting plasma glucose (FPG) tests indicate that FPG is \>=126 mg/dL (7.0 mmol/L). New onset diabetes mellitus (NODM) = post-transplant diabetes mellitus (PTDM)

Outcome measures

Outcome measures
Measure	Cyclosporine n=162 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=168 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=156 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36 Month 12	9.9 percentage of participants Interval 5.3 to 14.5	4.2 percentage of participants Interval 1.1 to 7.2	7.1 percentage of participants Interval 3.0 to 11.1
Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36 Month 24	10.5 percentage of participants Interval 5.8 to 15.2	5.4 percentage of participants Interval 2.0 to 8.8	8.3 percentage of participants Interval 4.0 to 12.7
Percent of Participants With Incidence of New Onset Diabetes Mellitus by Month 36 Month 36	11.1 percentage of participants Interval 6.3 to 16.0	6.5 percentage of participants Interval 2.8 to 10.3	10.3 percentage of participants Interval 5.5 to 15.0

SECONDARY outcome

Timeframe: Month 36

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

This analysis was based on all participants who had been followed up at least 1092 days after transplantation. Hypertension was defined in according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. In addition, all participants who had a SBP \< 130 mm Hg and a DBP \< 80 mm Hg who received an antihypertensive medication(s) for the indication of hypertension or with a medical history of hypertension were included in this definition. Systolic blood pressure = SBP; Diastolic blood pressure = DBP

Outcome measures

Outcome measures
Measure	Cyclosporine n=182 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=199 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=192 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants Using At Least One Anti-Hypertensive Medication to Control Hypertension at Month 36	92.9 percentage of participants Interval 89.12 to 96.6	81.9 percentage of participants Interval 76.56 to 87.36	83.9 percentage of participants Interval 78.65 to 89.06

SECONDARY outcome

Timeframe: Month 12

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

The incidence of hypertension was defined as the proportion of participants who developed hypertension after randomization and transplantation. Specifically, the incidence of hypertension was assessed only after the Week 4 visit. This period allowed for adequate stabilization and resolution of transient changes. If participants received antihypertensive medication for the indication of hypertension at this (or later) time point, they were considered to have developed hypertension. Hypertension was defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for subjects with chronic kidney disease. This definition was based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP

Outcome measures

Outcome measures
Measure	Cyclosporine n=4 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=13 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=7 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants With Incidence of Hypertension Post-Transplantation at Month 12	75.0 percentage of participants Interval 19.4 to 99.4	53.8 percentage of participants Interval 26.7 to 80.9	57.1 percentage of participants Interval 18.4 to 90.1

SECONDARY outcome

Timeframe: Month 12

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

The prevalence of hypertension was defined as the proportion of participants at any given time who meet the definition of hypertension. Hypertension defined according to the Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure for participants with chronic kidney disease. This definition is based upon SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg. Systolic blood pressure = SBP; Diastolic blood pressure = DBP

Outcome measures

Outcome measures
Measure	Cyclosporine n=221 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=226 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=219 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants With Prevalence of Hypertension Post-Transplantation at Month 12	91.0 percentage of participants Interval 87.17 to 94.73	89.8 percentage of participants Interval 85.88 to 93.76	88.6 percentage of participants Interval 84.37 to 92.8

SECONDARY outcome

Timeframe: Months 12, 24, 36

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Outcome measures

Outcome measures
Measure	Cyclosporine n=188 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=193 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=191 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Mean Systolic Blood Pressure and Diastolic Blood Pressure Diastolic; Month 36 (n=145, 180, 166)	79.5 mmHg Standard Deviation 9.16	76.6 mmHg Standard Deviation 9.75	76.1 mmHg Standard Deviation 11.20
Mean Systolic Blood Pressure and Diastolic Blood Pressure Systolic; Month 12 (n=188, 193, 191)	138.7 mmHg Standard Deviation 19.98	131.4 mmHg Standard Deviation 16.54	132.7 mmHg Standard Deviation 16.21
Mean Systolic Blood Pressure and Diastolic Blood Pressure Diastolic; Month 12 (n=188, 193, 191)	81.9 mmHg Standard Deviation 11.10	78.7 mmHg Standard Deviation 10.91	79.3 mmHg Standard Deviation 11.54
Mean Systolic Blood Pressure and Diastolic Blood Pressure Systolic; Month 24 (n=160, 185, 174)	135.4 mmHg Standard Deviation 19.71	130.5 mmHg Standard Deviation 17.35	129.8 mmHg Standard Deviation 16.84
Mean Systolic Blood Pressure and Diastolic Blood Pressure Diastolic; Month 24 (n=160, 185, 174)	80.3 mmHg Standard Deviation 10.20	78.3 mmHg Standard Deviation 10.51	77.8 mmHg Standard Deviation 10.31
Mean Systolic Blood Pressure and Diastolic Blood Pressure Systolic; Month 36 (n=145, 180, 166)	133.5 mmHg Standard Deviation 17.93	127.7 mmHg Standard Deviation 16.48	126.0 mmHg Standard Deviation 16.14

SECONDARY outcome

Timeframe: Day 1 to Month 12

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with baseline hypertension

Controlled hypertension was defined as a SBP \< 130 mm Hg and a DBP \< 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP \< 130 mm Hg and a DBP \< 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP

Outcome measures

Outcome measures
Measure	Cyclosporine n=182 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=182 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=183 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants at Baseline With Controlled Hypertension Post Transplantation by Month 12	21.4 percentage of participants Interval 15.5 to 27.4	28.6 percentage of participants Interval 22.0 to 35.1	24.6 percentage of participants Interval 18.4 to 30.8

SECONDARY outcome

Timeframe: Month 12

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

The prevalence of controlled hypertension was defined as the proportion of participants at any given time who met the definition of controlled hypertension. Controlled hypertension was defined as a SBP \< 130 mm Hg and a DBP \< 80 mm Hg while receiving an antihypertensive medication for the indication of hypertension or receiving an antihypertensive medication for another indication with a medical history of hypertension. Participants with a SBP \< 130 mm Hg and a DBP \< 80 mm Hg who were prescribed an antihypertensive medication(s) for an indication(s) other than hypertension (eg, beta blockers for migraine prophylaxis) with no medical history of hypertension were not considered to have either hypertension or controlled hypertension. Systolic blood pressure = SBP; Diastolic blood pressure = DBP

Outcome measures

Outcome measures
Measure	Cyclosporine n=186 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=193 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=190 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants With Prevalence of Controlled Hypertension at Month 12	21.0 percentage of participants Interval 15.12 to 26.82	28.0 percentage of participants Interval 21.65 to 34.31	24.7 percentage of participants Interval 18.6 to 30.87

SECONDARY outcome

Timeframe: Randomization to Month 12

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Incidence of dyslipidemia was defined as the proportion of participants who developed dyslipidemia after randomization and transplantation. Dyslipidemia was defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia = hypertriglyceridemia (TGs \>= 500 milligrams/deciliter (mg/dL) \[5.65 mmol/L\]), hypercholesterolemia (LDL \>= 100 mg/dL \[2.59 mmol/L\]), or elevated non-HDL (non-HDL \>= 130 mg/dL \[3.36 mmol/L\]) in the presence of high TGs (TGs \>= 200 mg/dL \[2.26 mmol/L\]). The TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N \>=5. Otherwise exact method is used.

Outcome measures

Outcome measures
Measure	Cyclosporine n=75 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=94 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=79 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Non-dyslipidemic Participants With Incidence of Dyslipidemia Post-Transplantation by Month 12	80.0 percentage of participants Interval 70.9 to 89.1	63.8 percentage of participants Interval 54.1 to 73.5	70.9 percentage of participants Interval 60.9 to 80.9

SECONDARY outcome

Timeframe: Month 12

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

The prevalence of dyslipidemia was defined as the proportion of participants at any given time who met the definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs \>= 500 milligrams/deciliter (mg/dL) \[5.65 mmol/L\]), hypercholesterolemia (LDL \>= 100 mg/dL \[2.59 mmol/L\]), or elevated non-HDL (non-HDL \>= 130 mg/dL \[3.36 mmol/L\]) in the presence of high TGs (TGs \>= 200 mg/dL \[2.26 mmol/L\]). TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N \>=5. Otherwise exact method is used.

Outcome measures

Outcome measures
Measure	Cyclosporine n=221 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=226 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=219 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants With Prevalence of Dyslipidemia at Month 12	52.9 percentage of participants Interval 46.4 to 59.5	44.7 percentage of participants Interval 38.2 to 51.2	46.1 percentage of participants Interval 39.5 to 52.7

SECONDARY outcome

Timeframe: Month 12

Population: All randomized and transplanted participants, intent-to-treat (ITT) population

Prevalence of controlled dyslipidemia = the proportion of participants at any given time who met the stated definition of dyslipidemia. Dyslipidemia defined in accordance with recent guidelines from the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI). Dyslipidemia defined as hypertriglyceridemia (TGs \>= 500 milligrams/deciliter (mg/dL) \[5.65 mmol/L\]), hypercholesterolemia (LDL \>= 100 mg/dL \[2.59 mmol/L\]), or elevated non-HDL (non-HDL \>= 130 mg/dL \[3.36 mmol/L\]) in the presence of high TGs (TGs \>= 200 mg/dL \[2.26 mmol/L\]). Controlled dyslipidemia defined as participants who received successful pharmacologic treatment for 1 of the above stated dyslipidemias, and their lipid values fell below the thresholds described. TG = triglyceride; LDL = low density lipoprotein; HDL = high density lipoprotein; millimole/Liter (mmol/L). For 95% CI within each group, normal approximation is used if N \>=5. Otherwise exact method is used.

Outcome measures

Outcome measures
Measure	Cyclosporine n=221 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=226 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=219 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants With Controlled Dyslipidemia at Month 12	18.1 percentage of participants Interval 13.0 to 23.2	15.5 percentage of participants Interval 10.8 to 20.2	15.5 percentage of participants Interval 10.7 to 20.3

SECONDARY outcome

Timeframe: Month 36

Population: All randomized and transplanted participants that received at least one hyperlipidemic medication; Completer analysis is based on all participants who have been followed up at least 1092 days after transplantation.

An intensity level was associated with the dose level of the statin based anti-hyperlipidemic agent. Any other agent (i.e., non-statin therapy) used as an antihyperlipidemic were considered Level I treatment intensity. Multiple daily dose levels during a period were averaged to compute the daily dose during that period. Level I = 20 mg fluvastatin (flu), 10 mg lovastatin (lova), 10 mg pravastatin (prav), 5-10 mg simvastatin (sim); Level II = 10 mg atorvastatin (atorv), 40 mg flu, 20 mg lova, 20 mg prav, 5 mg rosuvastatin (rosu), 20 mg sim, 10/10 vytorin; Level III = 20 mg atorv, 80 mg flu, 40 mg lova, 40 mg prav, 10 mg rosu, 40 mg sim, 10/20 vytorin; Level IV = 40 mg atorv, 80 mg lova, 80 mg prav, 20 mg rosu, 80 mg sim, 10/40 vytorin; Level V = 80 mg atorv, 40 mg rosu, 10/80 vytorin. Concomitant use of a statin and an agent of another class elevated the intensity level of the statin therapy by 1 level; therefore, an intensity level of greater than V was possible.

Outcome measures

Outcome measures
Measure	Cyclosporine n=103 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=92 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=92 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Number of Participants With Antihyperlipidemic Medication by Intensity Level Intensity Level I	17 participants	15 participants	17 participants
Number of Participants With Antihyperlipidemic Medication by Intensity Level Intensity Level II	46 participants	27 participants	39 participants
Number of Participants With Antihyperlipidemic Medication by Intensity Level Intensity Level III	27 participants	32 participants	23 participants
Number of Participants With Antihyperlipidemic Medication by Intensity Level Intensity Level IV	8 participants	16 participants	9 participants
Number of Participants With Antihyperlipidemic Medication by Intensity Level Intensity Level V	4 participants	1 participants	4 participants
Number of Participants With Antihyperlipidemic Medication by Intensity Level Intensity Level VI	1 participants	1 participants	0 participants

SECONDARY outcome

Timeframe: Month 36

Population: All randomized and transplanted participants, intent-to-treat (ITT) population; Completer analysis is based on all participants who have been followed up at least 1092 days after transplantation.

This analysis is based on all participants who were followed up at least 1092 days after transplantation.

Outcome measures

Outcome measures
Measure	Cyclosporine n=182 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=199 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=192 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants Using At Least One Anti-Hyperlipidemic Medication	56.6 percentage of participants Interval 49.4 to 63.8	46.2 percentage of participants Interval 39.3 to 53.2	47.9 percentage of participants Interval 40.9 to 55.0

SECONDARY outcome

Timeframe: Months 12, 24, 36

Population: All randomized and transplanted participants, intent-to-treat (ITT) population

Lipid parameters included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, non-HDL cholesterol, and triglycerides (TGs).

Outcome measures

Outcome measures
Measure	Cyclosporine n=189 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=195 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=192 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Mean Value of Lipid Parameters HDL Cholesterol; Month 36 (n=154, 184, 176)	48.5 mg/dL Standard Deviation 14.27	48.9 mg/dL Standard Deviation 15.37	48.6 mg/dL Standard Deviation 16.86
Mean Value of Lipid Parameters LDL Cholesterol; Month 36 (n=142, 170, 161)	107.6 mg/dL Standard Deviation 37.66	96.7 mg/dL Standard Deviation 36.53	92.5 mg/dL Standard Deviation 33.78
Mean Value of Lipid Parameters Triglyceride; Month 36 (n=142, 170, 161)	179.1 mg/dL Standard Deviation 97.07	132.7 mg/dL Standard Deviation 68.69	144.0 mg/dL Standard Deviation 81.48
Mean Value of Lipid Parameters non-HDL Cholesterol; Month 12 (n=189, 195, 192)	144.1 mg/dL Standard Deviation 47.31	131.5 mg/dL Standard Deviation 38.18	131.7 mg/dL Standard Deviation 36.76
Mean Value of Lipid Parameters Total Cholesterol; Month 12 (n=189, 195, 192)	191.5 mg/dL Standard Deviation 49.29	182.4 mg/dL Standard Deviation 39.78	181.3 mg/dL Standard Deviation 39.92
Mean Value of Lipid Parameters HDL Cholesterol; Month 12 (n=189, 195, 192)	47.4 mg/dL Standard Deviation 13.33	50.8 mg/dL Standard Deviation 15.98	49.7 mg/dL Standard Deviation 15.69
Mean Value of Lipid Parameters LDL Cholesterol; Month 12 (n=187, 186, 183)	107.3 mg/dL Standard Deviation 39.60	102.1 mg/dL Standard Deviation 33.40	100.8 mg/dL Standard Deviation 29.48
Mean Value of Lipid Parameters Triglyceride; Month 12 (n=187, 186, 183)	184.6 mg/dL Standard Deviation 106.42	149.4 mg/dL Standard Deviation 87.25	155.0 mg/dL Standard Deviation 85.08
Mean Value of Lipid Parameters non-HDL Cholesterol; Month 24 (n=166, 190, 181)	145.1 mg/dL Standard Deviation 39.52	126.7 mg/dL Standard Deviation 38.48	127.0 mg/dL Standard Deviation 36.76
Mean Value of Lipid Parameters Total Cholesterol; Month 24 (n=166, 190, 181)	193.5 mg/dL Standard Deviation 40.23	175.3 mg/dL Standard Deviation 42.38	175.4 mg/dL Standard Deviation 40.03
Mean Value of Lipid Parameters HDL ; Month 24 (n=166, 190, 181)	48.4 mg/dL Standard Deviation 13.74	48.6 mg/dL Standard Deviation 15.28	48.5 mg/dL Standard Deviation 14.92
Mean Value of Lipid Parameters LDL Cholesterol; Month 24 (n=164, 186, 168)	109.1 mg/dL Standard Deviation 35.92	98.6 mg/dL Standard Deviation 33.71	96.5 mg/dL Standard Deviation 30.52
Mean Value of Lipid Parameters Triglyceride; Month 24 (n=164, 186, 168)	179.5 mg/dL Standard Deviation 97.51	143.4 mg/dL Standard Deviation 88.97	151.2 mg/dL Standard Deviation 95.88
Mean Value of Lipid Parameters non-HDL Cholesterol; Month 36 (n=154, 184, 176)	142.2 mg/dL Standard Deviation 43.19	122.4 mg/dL Standard Deviation 40.12	122.1 mg/dL Standard Deviation 38.78
Mean Value of Lipid Parameters Total Cholesterol; Month 36 (n=154, 184, 176)	190.7 mg/dL Standard Deviation 45.28	171.3 mg/dL Standard Deviation 45.78	170.7 mg/dL Standard Deviation 43.26

SECONDARY outcome

Timeframe: Randomization to Month 36

Population: All randomized and transplanted participants, intent to treat (ITT) population

Prevalence of AR = participants with the stated definition of AR at any given time. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification.

Outcome measures

Outcome measures
Measure	Cyclosporine n=221 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=226 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=219 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36 Month 6 (n=221, 226, 219)	5.4 percentage of participants Interval 2.4 to 8.4	16.8 percentage of participants Interval 11.9 to 21.7	21.9 percentage of participants Interval 16.4 to 27.4
Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36 Month 24 (n=221, 226, 219)	9.0 percentage of participants Interval 5.3 to 12.8	17.3 percentage of participants Interval 12.3 to 22.2	24.2 percentage of participants Interval 18.5 to 29.9
Percent of Participants With Prevalence of Acute Rejection (AR) by Month 36 Month 36 (n=221, 226, 219)	9.5 percentage of participants Interval 5.6 to 13.4	17.3 percentage of participants Interval 12.3 to 22.2	24.2 percentage of participants Interval 18.5 to 29.9

SECONDARY outcome

Timeframe: Randomization to Month 36

Population: All randomized and transplanted participants, intent to treat (ITT) population

Acute rejection was defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted.

Outcome measures

Outcome measures
Measure	Cyclosporine n=221 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=226 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=219 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 Mild Acute (IA); Month 6	1 participants	4 participants	7 participants
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 Mild Acute (IB); Month 6	5 participants	9 participants	3 participants
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 Moderate Acute (IIA); Month 6	5 participants	14 participants	16 participants
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 Moderate Acute (IIB); Month 6	1 participants	10 participants	20 participants
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 Severe Acute (III); Month 6	0 participants	1 participants	2 participants
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 Mild Acute (IA); Month 12	3 participants	4 participants	7 participants
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 Mild Acute (IB); Month 12	5 participants	8 participants	3 participants
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 Moderate Acute (IIA); Month 12	6 participants	16 participants	17 participants
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 Moderate Acute (IIB); Month 12	2 participants	10 participants	20 participants
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 Severe Acute (III); Month 12	0 participants	1 participants	2 participants
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 Mild Acute (IA); Month 24	4 participants	4 participants	7 participants
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 Mild Acute (IB); Month 24	7 participants	8 participants	3 participants
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 Moderate Acute (IIA); Month 24	6 participants	16 participants	18 participants
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 Moderate Acute (IIB); Month 24	3 participants	10 participants	22 participants
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 Severe Acute (III); Month 24	0 participants	1 participants	3 participants
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 Mild Acute (IA); Month 36	5 participants	4 participants	7 participants
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 Mild Acute (IB); Month 36	7 participants	8 participants	3 participants
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 Moderate Acute (IIA); Month 36	6 participants	16 participants	18 participants
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 Moderate Acute (IIB); Month 36	3 participants	10 participants	22 participants
Number of Participants With Acute Rejection (AR) Post-transplant in Terms of Severity Using Banff Grades by Month 36 Severe Acute (III); Month 36	0 participants	1 participants	3 participants

SECONDARY outcome

Timeframe: Randomization to Month 12

Population: All randomized and transplanted participants, intent to treat (ITT) population

A participant was considered to have delayed graft function (DGF), if treated with dialysis within the first week (Day 1 - 8) after transplantation. The use of polyclonal antilymphocyte preparations (LDT) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated DGF following transplantation and were not permitted in belatacept-treated participants, except for the treatment of acute rejection. Participants treated with LDT began CsA at the discretion of the investigator by Day 7. LDT could also have been used in participants who met \>= 1 of the following criteria, observed in the presence of a transplant artery and vein and no evidence of hydronephrosis by sonogram: Urine output \< 250 mL/12 hours, no significant improvement (\< 1 milligram per deciliter (mg/dL)) in serum creatinine from baseline value over the first 24 - 72 hours post-transplant, or dialysis treatment.

Outcome measures

Outcome measures
Measure	Cyclosporine n=221 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=226 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=219 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants Using Polyclonal Antilymphocyte Preparations for Impaired Renal Function and Anticipated Delayed Graft Function by Month 12	3.6 percentage of participants Interval 1.2 to 6.1	0.4 percentage of participants Interval 0.0 to 2.4	0.5 percentage of participants Interval 0.0 to 2.5

SECONDARY outcome

Timeframe: Randomization to Month 36

Population: All randomized and transplanted participants, intent to treat (ITT) population

The use of LDT (thymoglobulin or antithymocyte gamma globulin \[ATGAM\]) was permitted only for participants randomized to cyclosporine (CsA) who experienced impaired renal allograft function and anticipated delayed graft function following transplantation. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence (an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed) and biopsy confirmation. AR defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Only the episode with the highest Banff grade for each participant was counted.

Outcome measures

Outcome measures
Measure	Cyclosporine n=221 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=226 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=219 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36 Month 6	0.5 percentage of participants	4.4 percentage of participants	5.9 percentage of participants
Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36 Month 12	0.9 percentage of participants	4.4 percentage of participants	5.9 percentage of participants
Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36 Month 24	1.4 percentage of participants	4.4 percentage of participants	5.9 percentage of participants
Percent of Participants Using Lymphocyte Depleting Therapy (LDT) for the Initial Treatment of Acute Rejection (AR) by Month 36 Month 36	1.8 percentage of participants	4.4 percentage of participants	5.9 percentage of participants

SECONDARY outcome

Timeframe: Randomization to Month 36

Population: All randomized and transplanted participants, intent to treat (ITT) population

Steroid-resistant acute rejection (AR) defined as the use of lymphocyte-depletion therapy following treatment with corticosteroids. AR defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Clinical evidence defined: either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 international standardized histopathological working classification of kidney transplant pathology. Only the episode with the highest Banff grade for each participant was counted.

Outcome measures

Outcome measures
Measure	Cyclosporine n=221 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=226 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=219 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36 Month 6	0.0 percentage of participants	4.0 percentage of participants	5.9 percentage of participants
Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36 Month 12	0.0 percentage of participants	5.3 percentage of participants	6.4 percentage of participants
Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36 Month 24	0.5 percentage of participants	5.3 percentage of participants	6.4 percentage of participants
Percent of Participants With Corticosteroid Resistant Acute Rejection (AR) by Month 36 Month 36	0.5 percentage of participants	5.3 percentage of participants	6.8 percentage of participants

SECONDARY outcome

Timeframe: Randomization to Month 12

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with at least one episode of AR up to Month 12

Acute rejection (AR) = a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater. Clinical evidence = if either a or b was satisfied: a: an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b: an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remains elevated within 14 days post-transplantation and clinical suspicion of acute rejection exists. Complete recovery following AR defined as serum creatinine \[SCr\] levels returned to baseline. Recovery calculated using 2 algorithms: Algorithm 1 = last laboratory measurement prior to onset of AR (baseline and first laboratory measurement after 84 days since onset of AR = resolution); Algorithm 2 = lowest laboratory measurement on or after transplantation and prior to onset day of AR (baseline and lowest laboratory measurement after onset on first AR up to Month 12 = resolution)

Outcome measures

Outcome measures
Measure	Cyclosporine n=16 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=39 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=48 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Number of Participants Who Recovered Completely From an Episode of Acute Rejection (AR) by Month 12 Algorithm 1	13 participants	29 participants	39 participants
Number of Participants Who Recovered Completely From an Episode of Acute Rejection (AR) by Month 12 Algorithm 2	13 participants	34 participants	43 participants

SECONDARY outcome

Timeframe: Month 12

Population: All randomized, transplanted, and treated participants; intent to treat (ITT) population with measurable component

Subclinical rejection defined as histological findings by the central pathologist consistent with acute rejection, but lacking its clinical correlate. Acute rejection defined as a clinico-pathological event requiring clinical evidence and renal biopsy confirmation demonstrating a Banff 97 classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the episode with the highest Banff grade for each participant was counted. Clinical evidence defined if either a or b was satisfied: a) an unexplained rise of serum creatinine ≥ 25% from baseline creatinine; b) an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of acute rejection existed. Allograft biopsies were evaluated by a blinded central independent pathologist using Banff 97 working classification of kidney transplant pathology.

Outcome measures

Outcome measures
Measure	Cyclosporine n=155 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=170 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=164 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants With Subclinical Rejection at Month 12	5.2 percentage of participants Interval 1.7 to 8.6	4.7 percentage of participants Interval 1.5 to 7.9	4.3 percentage of participants Interval 1.2 to 7.4

SECONDARY outcome

Timeframe: Randomization to Month 36

Population: All randomized and transplanted participants, intent to treat (ITT) population

Allograft rejection includes any episode of rejection including: clinically suspected rejection, treated rejection, any central biopsy-proven acute rejection (BPAR), and acute rejection (AR: a subset of BPAR) defined as central biopsy-proven rejection that was either clinically suspected by protocol-defined reasons or by other reasons and was treated. Acute rejection (AR) defined as a clinico-pathological event requiring clinical evidence ( either an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output; or fever and graft tenderness; or a serum creatinine that remained elevated within 14 days post-transplantation and clinical suspicion of AR) and renal biopsy confirmation biopsy demonstrating a Banff 97 working classification of kidney transplant pathology classification of Grade IA or greater, with higher scores indicating more severe rejection. Only the highest Banff grade for each participant was counted.

Outcome measures

Outcome measures
Measure	Cyclosporine n=221 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=226 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=219 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36 Month 6	43 participants	68 participants	70 participants
Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36 Month 12	56 participants	72 participants	75 participants
Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36 Month 24	63 participants	74 participants	81 participants
Number of Participants Treated for Acute Rejection (AR) Regardless of Histological Findings by Month 36 Month 36	69 participants	76 participants	82 participants

SECONDARY outcome

Timeframe: Months 6, 12, 24, 36

Population: All randomized and transplanted participants, intent to treat (ITT) population

SF-36 was a Participant-Reported Quality of Life (QoL) Short Form (SF) questionnaire measuring health-related quality of life (HRQL) covering 2 scale measures: physical component summary (PCS) and mental component summary (MCS). PCS represented by 4 domains: physical function, role limitations due to physical problems, pain, and general health perception. MCS represented by 4 domains: vitality, social function, role limitations due to emotional problems, and mental health. Their scores were computed based on weighted combinations of the 8 domain scores, which were transformed to a range from 0 to 100; 0= worst HRQL, 100=best HRQL. Higher scores reflect better health-related functional status. Scoring is standardized using the norm-based scoring method where data is scored in relation to the U.S. general population having a mean of 50 and a standard deviation of 10. Scores below 50 are below the U.S. general population norm and above 50 are above the U.S. general population norm.

Outcome measures

Outcome measures
Measure	Cyclosporine n=203 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=218 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=201 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Mean Value of Physical and Mental Components Using SF-36 Questionnaire Mental Component Score; Month 6 (n=191, 205, 189)	49.4 units on a scale Standard Deviation 11.08	49.9 units on a scale Standard Deviation 10.55	51.1 units on a scale Standard Deviation 10.53
Mean Value of Physical and Mental Components Using SF-36 Questionnaire Physical Component Score; Month 6 (n=191,205,189)	47.3 units on a scale Standard Deviation 8.91	48.9 units on a scale Standard Deviation 8.59	49.2 units on a scale Standard Deviation 7.58
Mean Value of Physical and Mental Components Using SF-36 Questionnaire Mental Component Score; Month 12 (n=198,210,194)	49.5 units on a scale Standard Deviation 10.78	50.3 units on a scale Standard Deviation 10.08	49.9 units on a scale Standard Deviation 10.54
Mean Value of Physical and Mental Components Using SF-36 Questionnaire Physical Component Score; Month 12 (n=198,210,194)	47.5 units on a scale Standard Deviation 9.34	49.6 units on a scale Standard Deviation 8.18	50.3 units on a scale Standard Deviation 8.21
Mean Value of Physical and Mental Components Using SF-36 Questionnaire Mental Component Score; Month 24 (n=200,214,198)	48.3 units on a scale Standard Deviation 11.14	49.6 units on a scale Standard Deviation 10.77	48.8 units on a scale Standard Deviation 11.03
Mean Value of Physical and Mental Components Using SF-36 Questionnaire Physical Component Score; Month 24 (n=200,214,198)	47.3 units on a scale Standard Deviation 9.50	49.0 units on a scale Standard Deviation 8.77	49.9 units on a scale Standard Deviation 8.03
Mean Value of Physical and Mental Components Using SF-36 Questionnaire Mental Component Score; Month 36 (n=203,218,201)	46.9 units on a scale Standard Deviation 11.60	48.7 units on a scale Standard Deviation 11.26	48.3 units on a scale Standard Deviation 11.50
Mean Value of Physical and Mental Components Using SF-36 Questionnaire Physical Component Score; Month 36 (n=203,218,201)	47.1 units on a scale Standard Deviation 9.47	49.2 units on a scale Standard Deviation 9.15	48.7 units on a scale Standard Deviation 8.90

SECONDARY outcome

Timeframe: Months 6, 12, 24, 36

Population: All randomized and transplanted participants, intent to treat (ITT) population

Outcome measures

Outcome measures
Measure	Cyclosporine n=205 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=219 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=206 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Bodily Pain, Month 6 (n=193, 207, 193)	50.6 units on a scale Standard Deviation 10.96	52.5 units on a scale Standard Deviation 10.10	52.7 units on a scale Standard Deviation 10.04
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire General Health, Month 6 (n=193, 207, 194)	47.9 units on a scale Standard Deviation 10.08	48.2 units on a scale Standard Deviation 9.67	49.0 units on a scale Standard Deviation 8.66
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Mental Health, Month 6 (n=192, 206, 194)	50.1 units on a scale Standard Deviation 11.08	50.3 units on a scale Standard Deviation 10.33	51.3 units on a scale Standard Deviation 10.78
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Physical Functioning, Month 6 (n=193, 207, 194)	47.4 units on a scale Standard Deviation 9.13	48.3 units on a scale Standard Deviation 9.01	48.0 units on a scale Standard Deviation 8.81
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Role Emotional, Month 6 (n=192, 206, 191)	44.6 units on a scale Standard Deviation 12.31	46.0 units on a scale Standard Deviation 11.19	46.8 units on a scale Standard Deviation 10.55
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Role-Physical, Month 6 (n=192, 207, 192)	43.2 units on a scale Standard Deviation 11.08	45.2 units on a scale Standard Deviation 10.34	46.7 units on a scale Standard Deviation 9.06
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Social Functioning, Month 6 (n=193, 207, 194)	47.5 units on a scale Standard Deviation 10.68	47.8 units on a scale Standard Deviation 10.41	47.9 units on a scale Standard Deviation 10.65
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Vitality, Month 6 (n=192, 206, 194)	54.0 units on a scale Standard Deviation 10.27	55.5 units on a scale Standard Deviation 9.75	56.2 units on a scale Standard Deviation 9.29
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Bodily Pain, Month 12 (n=200, 213, 199)	50.8 units on a scale Standard Deviation 10.79	52.7 units on a scale Standard Deviation 9.67	53.7 units on a scale Standard Deviation 9.60
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire General Health, Month 12 (n=200, 214, 199)	46.9 units on a scale Standard Deviation 9.98	48.8 units on a scale Standard Deviation 9.57	49.2 units on a scale Standard Deviation 8.85
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Mental Health, Month 12 (n=200, 213, 199)	49.8 units on a scale Standard Deviation 10.99	50.7 units on a scale Standard Deviation 10.64	50.3 units on a scale Standard Deviation 10.29
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Physical Functioning, Month 12 (n=200, 214, 198)	47.2 units on a scale Standard Deviation 9.77	49.0 units on a scale Standard Deviation 8.88	48.1 units on a scale Standard Deviation 9.84
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Role Emotional, Month 12 (n=198, 213, 196)	45.8 units on a scale Standard Deviation 11.36	46.8 units on a scale Standard Deviation 10.82	45.9 units on a scale Standard Deviation 11.27
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Role-Physical, Month 12 (n=199, 213, 196)	45.0 units on a scale Standard Deviation 10.78	47.1 units on a scale Standard Deviation 10.00	47.5 units on a scale Standard Deviation 9.90
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Social Functioning, Month 12 (n=200, 213, 199)	47.6 units on a scale Standard Deviation 10.26	48.4 units on a scale Standard Deviation 9.61	49.1 units on a scale Standard Deviation 9.80
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Vitality, Month 12 (n=200, 213, 199)	53.3 units on a scale Standard Deviation 10.01	55.7 units on a scale Standard Deviation 9.81	56.0 units on a scale Standard Deviation 9.34
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Bodily Pain, Month 24 (n=203, 219, 205)	51.0 units on a scale Standard Deviation 10.82	51.4 units on a scale Standard Deviation 10.51	52.5 units on a scale Standard Deviation 10.47
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire General Health, Month 24 (n=203, 219, 205)	46.2 units on a scale Standard Deviation 10.07	48.4 units on a scale Standard Deviation 9.61	48.7 units on a scale Standard Deviation 9.45
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Mental Health, Month 24 (n=201, 215, 199)	48.5 units on a scale Standard Deviation 11.13	49.7 units on a scale Standard Deviation 10.89	49.3 units on a scale Standard Deviation 10.85
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Physical Functioning, Month 24 (n=203, 219, 205)	46.5 units on a scale Standard Deviation 10.69	48.7 units on a scale Standard Deviation 9.76	48.0 units on a scale Standard Deviation 10.24
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Role Emotional, Month 24 (n=202, 218, 205)	44.8 units on a scale Standard Deviation 12.54	46.4 units on a scale Standard Deviation 10.89	46.0 units on a scale Standard Deviation 10.88
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Role-Physical, Month 24 (n=203, 219, 204)	44.1 units on a scale Standard Deviation 11.61	46.6 units on a scale Standard Deviation 10.39	48.0 units on a scale Standard Deviation 9.33
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Social Functioning, Month 24 (n=203, 219, 205)	47.3 units on a scale Standard Deviation 10.64	48.6 units on a scale Standard Deviation 10.28	47.7 units on a scale Standard Deviation 10.23
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Vitality, Month 24 (n=201, 215, 200)	52.5 units on a scale Standard Deviation 10.58	54.5 units on a scale Standard Deviation 10.30	54.2 units on a scale Standard Deviation 10.30
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Bodily Pain, Month 36 (n=204, 219, 205)	50.0 units on a scale Standard Deviation 11.40	52.3 units on a scale Standard Deviation 10.40	51.0 units on a scale Standard Deviation 11.05
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire General Health, Month 36 (n=205, 219, 206)	45.5 units on a scale Standard Deviation 10.12	47.7 units on a scale Standard Deviation 10.45	47.5 units on a scale Standard Deviation 9.93
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Mental Health, Month 36 (n=203, 219, 204)	47.4 units on a scale Standard Deviation 11.64	48.9 units on a scale Standard Deviation 11.52	48.7 units on a scale Standard Deviation 11.43
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Physical Functioning, Month 36 (n=204, 218, 206)	46.8 units on a scale Standard Deviation 9.92	48.1 units on a scale Standard Deviation 10.22	47.8 units on a scale Standard Deviation 10.12
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Role Emotional, Month 36 (n=204, 219, 205)	43.5 units on a scale Standard Deviation 12.18	46.0 units on a scale Standard Deviation 11.85	45.3 units on a scale Standard Deviation 11.67
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Role-Physical, Month 36 (n=204, 219, 205)	43.6 units on a scale Standard Deviation 10.73	46.3 units on a scale Standard Deviation 11.03	46.2 units on a scale Standard Deviation 10.03
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Social Functioning, Month 36 (n=204, 219, 206)	46.6 units on a scale Standard Deviation 10.68	48.1 units on a scale Standard Deviation 10.28	47.1 units on a scale Standard Deviation 10.66
Mean Value of the Eight Domain Scores of Quality of Life Using SF-36 Questionnaire Vitality, Month 36 (n=203, 219, 204)	51.4 units on a scale Standard Deviation 10.48	53.6 units on a scale Standard Deviation 11.38	53.4 units on a scale Standard Deviation 10.46

SECONDARY outcome

Timeframe: Months 6, 12, 24, 36

Population: All randomized and transplanted participants, intent to treat (ITT) population.

The Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD-59R) was used to assess the occurrence (never, occasionally, regularly, almost always, always) and distress (0=no distress to 4=terrible distress) of symptoms associated with immunosuppressive therapies. Ridit (relative to an identified distribution) analysis (Fleiss JL. Statistical methods for rates and proportions. New York: John Wiley \& Sons, Inc. 1991) was used. Ridit scores were calculated at baseline and at 6, 12, 24, and 36 months for overall symptom occurrence score and overall symptom distress. The Ridit score reflects the probability that a score observed for an individual randomly selected from a group would be higher (worse symptom) than a score observed for a randomly selected individual from the reference group. The reference group was constituted by the frequency distribution of the responses of all participants on all items at baseline. The ridit of the reference group is by definition, 0.5.

Outcome measures

Outcome measures
Measure	Cyclosporine n=186 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=197 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=187 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) Symptom Distress, Month 6 (n=157, 164, 155)	0.4643 Ridit score Standard Error 0.00452	0.4407 Ridit score Standard Error 0.00404	0.4451 Ridit score Standard Error 0.00422
Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) Symptom Occurrence, Month 6 (n=166, 176, 165)	0.4721 Ridit score Standard Error 0.00463	0.4495 Ridit score Standard Error 0.00425	0.4459 Ridit score Standard Error 0.00432
Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) Symptom Distress, Month 12 (n=169, 185, 169)	0.4751 Ridit score Standard Error 0.00453	0.4510 Ridit score Standard Error 0.00397	0.4546 Ridit score Standard Error 0.00421
Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) Symptom Occurrence, Month 12 (n=173, 188, 173)	0.4776 Ridit score Standard Error 0.00458	0.4519 Ridit score Standard Error 0.00411	0.4525 Ridit score Standard Error 0.00430
Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) Symptom Distress, Month 24 (n=182, 195, 179)	0.4798 Ridit score Standard Error 0.00443	0.4584 Ridit score Standard Error 0.00397	0.4646 Ridit score Standard Error 0.00424
Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) Symptom Occurrence, Month 24 (n=184, 197, 184)	0.4804 Ridit score Standard Error 0.00446	0.4574 Ridit score Standard Error 0.00406	0.4593 Ridit score Standard Error 0.00423
Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) Symptom Distress, Month 36 (n=184, 196, 183)	0.5000 Ridit score Standard Error 0.00456	0.4746 Ridit score Standard Error 0.00408	0.4892 Ridit score Standard Error 0.00442
Mean Relative to an Identified Distribution (Ridit) Value of Symptom Occurrence and Symptom Distress Using Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSDS-59R) Symptom Occurrence, Month 36 (n=186, 197, 187)	0.5000 Ridit score Standard Error 0.00459	0.4732 Ridit score Standard Error 0.00421	0.4846 Ridit score Standard Error 0.00441

SECONDARY outcome

Timeframe: Baseline to Months 6, 12, 24,and 36

Population: All randomized and transplanted participants, intent to treat (ITT) population

Outcome measures

Outcome measures
Measure	Cyclosporine n=192 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=203 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=193 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Mental Component Score; Month 6 (n=187, 197, 184)	5.4 units on a scale Standard Deviation 0.714	6.2 units on a scale Standard Deviation 0.695	7.3 units on a scale Standard Deviation 0.720
Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Physical Component Score; Month 6 (n=187, 197, 184	5.0 units on a scale Standard Deviation 0.580	6.2 units on a scale Standard Deviation 0.566	6.7 units on a scale Standard Deviation 0.585
Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Mental Component Score; Month 12 (n=192, 200, 189)	5.4 units on a scale Standard Deviation 0.687	6.8 units on a scale Standard Deviation 0.673	6.2 units on a scale Standard Deviation 0.693
Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Physical Component Score; Month 12 (n=192,200,189)	5.5 units on a scale Standard Deviation 0.589	7.1 units on a scale Standard Deviation 0.577	7.8 units on a scale Standard Deviation 0.594
Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Mental Component Score; Month 24 (n=191,202,193)	4.4 units on a scale Standard Deviation 0.732	5.7 units on a scale Standard Deviation 0.712	5.1 units on a scale Standard Deviation 0.728
Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Physical Component Score; Month 24 (n=191,202,193)	5.1 units on a scale Standard Deviation 0.601	6.5 units on a scale Standard Deviation 0.584	7.3 units on a scale Standard Deviation 0.597
Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Mental Component Score; Month 36 (n=190,203,191)	2.6 units on a scale Standard Deviation 0.756	5.1 units on a scale Standard Deviation 0.732	4.5 units on a scale Standard Deviation 0.754
Mean Changes in the Value of Physical and Mental Components Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Physical Component Score; Month 36 (n=190,203,191)	4.9 units on a scale Standard Deviation 0.633	6.5 units on a scale Standard Deviation 0.612	6.1 units on a scale Standard Deviation 0.631

SECONDARY outcome

Timeframe: Baseline to Months 6, 12, 24, and 36

Population: All randomized and transplanted participants, intent to treat (ITT) population

Outcome measures

Outcome measures
Measure	Cyclosporine n=194 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=207 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=197 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Bodily Pain, Month 6 (n=189,201,189)	2.9 units on a scale Standard Error 0.712	4.5 units on a scale Standard Error 0.691	4.6 units on a scale Standard Error 0.712
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 General Health, Month 6 (n=189,201,190)	6.7 units on a scale Standard Error 0.631	7.1 units on a scale Standard Error 0.612	7.3 units on a scale Standard Error 0.630
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Mental Health, Month 6 (n=188,198,190)	4.7 units on a scale Standard Error 0.716	5.2 units on a scale Standard Error 0.698	6.1 units on a scale Standard Error 0.712
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Physical Functioning, Month 6 (n=189,201,190)	4.7 units on a scale Standard Error 0.610	5.3 units on a scale Standard Error 0.592	5.6 units on a scale Standard Error 0.610
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Role Emotional, Month 6 (n=188,200,186)	4.7 units on a scale Standard Error 0.767	5.8 units on a scale Standard Error 0.744	6.9 units on a scale Standard Error 0.772
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Role-Physical, Month 6 (n=188,201,187)	6.4 units on a scale Standard Error 0.718	8.4 units on a scale Standard Error 0.694	9.6 units on a scale Standard Error 0.720
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Social Functioning, Month 6 (n=189,201,190)	6.0 units on a scale Standard Error 0.724	6.8 units on a scale Standard Error 0.702	6.9 units on a scale Standard Error 0.722
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Vitality, Month 6 (n=188,198,190)	7.5 units on a scale Standard Error 0.668	9.0 units on a scale Standard Error 0.651	9.9 units on a scale Standard Error 0.665
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Bodily Pain, Month 12 (n=194,205,195)	3.1 units on a scale Standard Error 0.665	4.8 units on a scale Standard Error 0.647	5.5 units on a scale Standard Error 0.664
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 General Health, Month 12 (n=194,206,195)	6.0 units on a scale Standard Error 0.638	7.7 units on a scale Standard Error 0.619	7.6 units on a scale Standard Error 0.636
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Mental Health, Month 12 (n=194,203,195)	4.4 units on a scale Standard Error 0.685	6.0 units on a scale Standard Error 0.670	5.0 units on a scale Standard Error 0.684
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Physical Functioning, Month 12 (n=194,206,194)	4.7 units on a scale Standard Error 0.640	6.2 units on a scale Standard Error 0.621	5.8 units on a scale Standard Error 0.641
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Role Emotional, Month 12 (n=192,205,191)	5.7 units on a scale Standard Error 0.765	6.6 units on a scale Standard Error 0.741	5.9 units on a scale Standard Error 0.768
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Role-Physical, Month 12 (n=193,205,191)	8.3 units on a scale Standard Error 0.716	10.3 units on a scale Standard Error 0.695	10.4 units on a scale Standard Error 0.720
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Social Functioning, Month 12 (n=194,205,195)	6.4 units on a scale Standard Error 0.669	7.7 units on a scale Standard Error 0.650	8.0 units on a scale Standard Error 0.667
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Vitality, Month 12 (n=194,203,195)	7.0 units on a scale Standard Error 0.651	9.2 units on a scale Standard Error 0.636	9.7 units on a scale Standard Error 0.649
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Bodily Pain, Month 24 (n=192,207,197)	3.2 units on a scale Standard Error 0.722	3.3 units on a scale Standard Error 0.696	4.1 units on a scale Standard Error 0.713
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 General Health, Month 24 (n=193,207,197)	5.1 units on a scale Standard Error 0.641	7.2 units on a scale Standard Error 0.619	6.8 units on a scale Standard Error 0.635
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Mental Health, Month 24 (n=193,203,195)	3.2 units on a scale Standard Error 0.710	4.6 units on a scale Standard Error 0.692	4.0 units on a scale Standard Error 0.706
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Physical Functioning, Month 24 (n=193,207,197)	4.1 units on a scale Standard Error 0.685	5.7 units on a scale Standard Error 0.662	5.5 units on a scale Standard Error 0.679
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Role Emotional, Month 24 (n=192,206,196)	4.7 units on a scale Standard Error 0.793	6.0 units on a scale Standard Error 0.766	5.9 units on a scale Standard Error 0.785
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Role-Physical, Month 24 (n=193,207,195)	7.4 units on a scale Standard Error 0.740	9.4 units on a scale Standard Error 0.715	10.7 units on a scale Standard Error 0.737
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Social Functioning, Month 24 (n=193, 207,197)	5.9 units on a scale Standard Error 0.722	7.4 units on a scale Standard Error 0.697	6.3 units on a scale Standard Error 0.715
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Vitality, Month 24 (n=193,203,196)	6.2 units on a scale Standard Error 0.700	7.9 units on a scale Standard Error 0.682	8.0 units on a scale Standard Error 0.695
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Bodily Pain, Month 36 (n=191,207,196)	2.3 units on a scale Standard Error 0.739	4.2 units on a scale Standard Error 0.710	3.0 units on a scale Standard Error 0.730
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 General Health, Month 36 (n=193,207,197)	4.1 units on a scale Standard Error 0.681	6.6 units on a scale Standard Error 0.657	5.8 units on a scale Standard Error 0.674
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Mental Health, Month 36 (n=191,204,195)	1.8 units on a scale Standard Error 0.754	4.1 units on a scale Standard Error 0.729	3.4 units on a scale Standard Error 0.746
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Physical Functioning, Month 36 (n=192,206,197)	4.4 units on a scale Standard Error 0.692	5.3 units on a scale Standard Error 0.668	5.1 units on a scale Standard Error 0.684
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Role Emotional, Month 36 (n=192,207,195)	3.3 units on a scale Standard Error 0.830	5.6 units on a scale Standard Error 0.800	5.0 units on a scale Standard Error 0.824
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Role-Physical, Month 36 (n=192,207,195)	6.8 units on a scale Standard Error 0.754	9.2 units on a scale Standard Error 0.727	8.9 units on a scale Standard Error 0.749
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Social Functioning, Month 36 (n=192,207,197)	5.1 units on a scale Standard Error 0.736	7.0 units on a scale Standard Error 0.708	5.6 units on a scale Standard Error 0.726
Mean Change in the Value of the Eight Domain Scores Using SF-36 From Baseline Up To Months 6, 12, 24, and 36 Vitality, Month 36 (n=191,204,195)	4.9 units on a scale Standard Error 0.721	7.3 units on a scale Standard Error 0.698	7.3 units on a scale Standard Error 0.714

SECONDARY outcome

Timeframe: Months 24, 36

Population: All randomized and transplanted participants, intent to treat (ITT) population. For 95% CI within each group, normal approximation is used in N\>=5. Otherwise exact method is used.

Outcome measures

Outcome measures
Measure	Cyclosporine n=221 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=226 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=219 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants Surviving With a Functioning Graft Month 24	90.5 percentage of participants Interval 86.6 to 94.4	94.7 percentage of participants Interval 91.8 to 97.6	94.1 percentage of participants Interval 90.9 to 97.2
Percent of Participants Surviving With a Functioning Graft Month 36	88.7 percentage of participants Interval 84.5 to 92.9	92.0 percentage of participants Interval 88.5 to 95.6	92.2 percentage of participants Interval 88.7 to 95.8

SECONDARY outcome

Timeframe: Randomization to Month 36

Population: All randomized and transplanted participants, intent to treat (ITT) population

Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine (SCr) ≥ 6.0 milligrams per deciliter (mg/dL) or 530 micromoles per liter (μmol/L) as determined by the central laboratory for ≥ 4 weeks or ≥ 56 consecutive days of dialysis or impairment of renal function to such a degree that the participant underwent retransplant. Acute rejection was defined as central biopsy proven rejection that was either (1) clinically suspected by protocol defined reasons or (2) clinically suspected by other reasons and treated. Death and graft loss were not imputed.

Outcome measures

Outcome measures
Measure	Cyclosporine n=221 Participants Cyclosporine (CsA): tablet, oral 1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)	Belatacept LI n=226 Participants Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)	Belatacept MI n=219 Participants Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36 Month 12	13.6 percentage of participants Interval 9.1 to 18.1	19.5 percentage of participants Interval 14.3 to 24.6	25.1 percentage of participants Interval 19.4 to 30.9
Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36 Month 24	18.1 percentage of participants Interval 13.0 to 23.2	19.9 percentage of participants Interval 14.7 to 25.1	27.9 percentage of participants Interval 21.9 to 33.8
Percent of Participants With Composite Endpoint or Death, Graft Loss or Acute Rejection by Month 36 Month 36	19.9 percentage of participants Interval 14.6 to 25.2	20.8 percentage of participants Interval 15.5 to 26.1	28.3 percentage of participants Interval 22.3 to 34.3

Adverse Events

Cyclosporine

Serious events: 167 serious events

Other events: 213 other events

Deaths: 0 deaths

Belatacept - LI

Serious events: 160 serious events

Other events: 222 other events

Deaths: 0 deaths

Belatacept - MI

Serious events: 164 serious events

Other events: 216 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER