Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant

Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - Extended Criteria Donors (BENEFIT-EXT)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00114777

Acronym

BENEFIT-EXT

Enrollment

595

Registered

2005-06-20

Start date

2005-02-28

Completion date

2014-09-30

Last updated

2017-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplantation

Brief summary

The purpose of this trial is to learn if Belatacept is effective and safe as a first line of immunosuppression treatment in patients undergoing a renal transplant where the donor kidney is obtained in patients with extended criteria.

Interventions

DRUGCyclosporin A

tablet, oral, 1st month target: 150-300 ng/mL, after 1st month target: 100-250 ng/mL, daily, 36 months, 100-250 ng/mL, daily, 84 months

DRUGBelatacept Less Intensive Regimen (LI)

solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months months, 5 mg/kg every 4 weeks, q 4 weeks, 84 months

DRUGBelatacept More Intensive Regimen (MI)

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, 5 mg/kg every 4 weeks, q 4 weeks, 84 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject is a first-time recipient of a kidney transplant from a deceased donor. * Specific donor criteria

Exclusion criteria

* Donor age \<10 years * Subjects receiving a concurrent solid organ or cell transplant (lung, heart, etc.) * Subjects with a positive T-cell lymphocytotoxic crossmatch. * Subjects who are positive for Hepatitis B or C, or HIV * Active tuberculosis * History of cancer in the last 5 years * History of substance abuse * Specific laboratory results are exclusionary * Mammography suspicious for cancer * Allergy to iodine * For Long-term extension study-Subjects who have completed three years of study treatment (through Week 156)

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Who Survived With a Graft at 12 Months Post-Transplant	Month 12 post-transplant	Participant and graft survival at 12 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 μmol/L) as determined by central laboratory for ≥4 weeks or 56 or more consecutive days of dialysis.
Percentage of Participants With a Measured Glomerular Filtration Rate (GFR) <60 mL/Min Per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/Min Per 1.73 m^2 From Month 3 to Month 12	From Month 3 to Month 12	GFR was assessed using a true measure of glomerular filtration via non-radiolabeled iothalamate clearance test using a validated procedure.

Secondary

Measure	Time frame	Description
Percentage of Participants Who Survived With a Graft at 24 and 36 Months Post-Transplant	Month 24 and Month 36 post-transplant	Participant and graft survival at 12 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss will be defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 μmol/L) as determined by central laboratory for ≥ 4 weeks or 56 or more consecutive days of dialysis.
Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months	Months 6, 12, 24, 36 and 84	GFR was assessed using a true measure of glomerular filtration via nonradiolabeled iothalamate clearance test using a validated procedure. Missing measured GFR assessments were imputed. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.
Change in Calculated GFR at Months 12, 24, 36 and 84	Baseline and Months 12, 24, 36 and 84	GFR was assessed using a true measure of glomerular filtration via nonradiolabeled iothalamate clearance test using a validated procedure. Missing measured GFR assessments were imputed. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.
Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months	Baseline and Months 12, 24 and 36	Participants were determined to have hypertension at a particular time point if standardized systolic blood pressure ≥ 130 mm Hg or standardized diastolic blood pressure ≥ 80 mm Hg or participant had received an antihypertensive medication(s) for hypertension. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.
Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36	Months 12, 24 and 36	Participants were determined to have hypertension at a particular time point if standardized systolic blood pressure ≥ 130 mm Hg or standardized diastolic blood pressure ≥ 80 mm Hg or subject had received an anti-hypertensive medication(s) for hypertension. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.
Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.	Months 12, 24 and 36	NODM was defined as participant who did not have diabetes prior to randomization. Participants were determined for NODM if the participant received an antidiabetic medication for a duration of at least 30 days, or at least two fasting plasma glucose (FPG) tests indicate that FPG is ≥ 126 mg/dL (7.0 mmol/L).
Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months	Months 12, 24 and 36	Participants were determined to have hypertension at a particular time point if standardized systolic blood pressure ≥ 130 mm Hg or standardized diastolic blood pressure ≥ 80 mm Hg or participant had received an anti-hypertensive medication(s) for hypertension. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.
Mean Framingham Risk Score From Baseline to Months 12, 24 and 36	Baseline and Months 12, 24 and 36	The risk score was calculated based on the total points from six variables: Age, Level of LDL-cholesterol, Level of HDL-cholesterol, Presence and severity of systolic or diastolic hypertension, Presence or absence of a history of diabetes mellitus and Presence or absence of a history recent cigarette smoking. Total scores can range from \<-3 to \>14, which translate to a 1% to 56% risk of developing coronary heart disease in 10 years. Totals in the 4 to 6 point range translate to a 7 to 11% risk and 8 to 10 point range translate to a 18 to 27% risk.
Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months	Months 12, 24 and 36	Dyslipidemia was defined as triglyceride ≥ 500 mg/dL \[5.65 mmol/L\], low density lipoprotein (LDL) ≥ 100 mg/dL \[2.59 mmol/L\], and non-elevated high density lipoprotein (HDL) ≥ 130 mg/dL \[3.36 mmol/L\]. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.
Measured Glomerular Filtration Rate (GFR) by Month 12 and 24	At Month 12 and Month 24	GFR was assessed using a true measure of glomerular filtration via nonradiolabeled iothalamate clearance test using a validated procedure. Missing measured GFR assessments were imputed. Here, 'n' signifies the number of evaluable participants for the reporting arm at the given time point. Missing measured GFR assessments were imputed to a GFR of zero.
Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84	Months 6, 12, 24, 36 and 84	Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Clinically suspected acute rejection was defined as an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output or fever and graft tenderness or serum creatinine that remains elevated within 14 days post--transplantation and clinical suspicion of acute rejection exists.
Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Months 6, 12, 24 and 36	Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Lymphocyte -depletion therapy for treatment of an episode of acute was defined as a participant treated with therapy and provided not treated with steroids earlier while steroid resistant acute rejection was defined as participants initially treated with steroids alone for suspected acute rejection for at least 2 days and then followed by the start of lymphocyte -depletion therapy.
Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Months 6, 12, 24, 36 and 84	Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Clinically suspected acute rejection was defined as an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output or fever and graft tenderness or serum creatinine that remains elevated within 14 days post--transplantation and clinical suspicion of acute rejection exists.
Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Baseline and Months 12, 24 and 36	The SF-36 is a 36-item self-administered questionnaire developed to assess health-related quality of life (QOL) and comprises 8 domains, including 4 physical (physical health, bodily pain, physical functioning and physical role limitations) and 4 mental (mental health, vitality, social functioning, and emotional role limitation) subscales. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QOL (0=Poorest Health; 100=Best Health). Mean change from baseline = post-baseline value - baseline value; a higher value signifies improvement.
Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months	Day 1 to Month 36	Participants with abnormal blood pressure, body weight and body temperature outside the defined normal range were graded as clinically significant vital signs by the investigator.
Number of Participants With Laboratory Test Abnormalities up to 36 Months	Day 1 to Month 36	Participants with laboratory values outside the defined normal range were graded as clinically significant laboratory abnormalities by the investigator. Subjects were analyzed for Alkaline phosphatase (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase(AST), Hemoglobin, Platelet Count, Leukocytes, Bilirubin, Creatinine, Calcium, Bicarbonate, Potassium, Magnesium, Sodium, Phosphorus, Albumin, Uric Acid and Protein. Laboratory abnormalities were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3. Here 'n' signifies those subjects evaluable for this measure at specified time points for each arm, respectively.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	Day 1 to Month 36	AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84	Day 1 to Month 84	AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Percentage of Participants With Graft Loss or Death to Month 84	Randomization to date of death, up to 84 months	Participant and graft survival at 84 months was summarized within each treatment group.
Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	Months 12, 24 and 36	Dyslipidemia was defined as triglyceride ≥ 500 mg/dL \[5.65 mmol/L\], low density lipoprotein (LDL) ≥ 100 mg/dL \[2.59 mmol/L\], and elevated non-high density lipoprotein (HDL) ≥ 130 mg/dL \[3.36 mmol/L\]. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.
Percentage of Participants With Chronic Allograft Nephropathy (CAN) at Month 12	At Month 12	Biopsy-proven CAN was determined by a blinded central histopathologist using the Banff 97 working classification of kidney transplant pathology. Onset of CAN was determined by the biopsy date when it was observed. Participants were considered as having CAN at 12 months if: CAN observed in a biopsy either prior to 12 months (including baseline biopsy) or first post 12 months biopsy; Participant had graft loss during the first year post transplant; no biopsy available post 12 months and CAN not observed in biopsies prior to 12 months; no biopsy available either prior to or post 12 months; and the measured glomerular filtration rate from Month 3 to Month 12 decreases at least 10 mL/min/1.73m\^2. All other participants with missing 12 month biopsy were considered having no CAN observed at 12 months.

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, France, Germany, Hungary, Italy, Norway, Poland, South Africa, Spain, Sweden, United Kingdom, United States

Participant flow

Pre-assignment details

595 participants enrolled, 578 randomized. Reasons for non-randomization included 13 subjects no longer met study criteria; 3 discontinued on sponsor's discretion; 1 due to other reason. Of those randomized, 543 were treated. Reasons for non-treatment were not specified.

Participants by arm

Arm	Count
Belatacept More Intensive (MI) Regimen Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.	184
Belatacept Less Intensive (LI) Regimen Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.	175
Cyclosporin A (CsA) Cyclosporine A 410 mg/kg was capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.	184
Total	543

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Long-Term Extension to Month 84	Administrative Reason by Sponsor	0	0	1
Long-Term Extension to Month 84	Adverse Event	15	14	7
Long-Term Extension to Month 84	Death	8	13	7
Long-Term Extension to Month 84	Lack of Efficacy	1	0	1
Long-Term Extension to Month 84	Lost to Follow-up	0	0	2
Long-Term Extension to Month 84	No Longer Met Study Criteria	1	0	1
Long-Term Extension to Month 84	Other	2	0	2
Long-Term Extension to Month 84	Poor or Non-Compliance	1	1	3
Long-Term Extension to Month 84	Withdrawal by Subject	2	1	6
Randomization to Month 36	Adverse Event	34	35	44
Randomization to Month 36	Death	10	4	3
Randomization to Month 36	Lack of Efficacy	19	15	17
Randomization to Month 36	No Longer Met Study Criteria	0	0	2
Randomization to Month 36	Other	9	3	12
Randomization to Month 36	Poor or Non-Compliance	0	0	1
Randomization to Month 36	Withdrawal by Subject	3	4	5

Baseline characteristics

Characteristic	Belatacept More Intensive (MI) Regimen	Belatacept Less Intensive (LI) Regimen	Cyclosporin A (CsA)	Total
Age, Continuous	56.7 years STANDARD_DEVIATION 12.6	56.1 years STANDARD_DEVIATION 12.4	55.7 years STANDARD_DEVIATION 12.2	56.2 years STANDARD_DEVIATION 12.4
Age, Customized 18 to 45 years	32 participants	35 participants	34 participants	101 participants
Age, Customized 46 to 65 years	100 participants	97 participants	108 participants	305 participants
Age, Customized more than 65 years	52 participants	43 participants	42 participants	137 participants
Sex: Female, Male Female	65 Participants	46 Participants	68 Participants	179 Participants
Sex: Female, Male Male	119 Participants	129 Participants	116 Participants	364 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	177 / 184	171 / 175	179 / 184
serious Total, serious adverse events	162 / 184	157 / 175	152 / 184

Outcome results

Primary

Percentage of Participants Who Survived With a Graft at 12 Months Post-Transplant

Participant and graft survival at 12 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss was defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 μmol/L) as determined by central laboratory for ≥4 weeks or 56 or more consecutive days of dialysis.

Time frame: Month 12 post-transplant

Population: All randomized and transplanted participants

Arm	Measure	Value (NUMBER)
Belatacept More Intensive (MI) Regimen	Percentage of Participants Who Survived With a Graft at 12 Months Post-Transplant	85.9 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Participants Who Survived With a Graft at 12 Months Post-Transplant	88.0 percentage of participants
Cyclosporin A (CsA)	Percentage of Participants Who Survived With a Graft at 12 Months Post-Transplant	84.8 percentage of participants

97.3% CI: [-7.2, 9.4]

97.3% CI: [-5, 11.4]

Primary

Percentage of Participants With a Measured Glomerular Filtration Rate (GFR) <60 mL/Min Per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/Min Per 1.73 m^2 From Month 3 to Month 12

GFR was assessed using a true measure of glomerular filtration via non-radiolabeled iothalamate clearance test using a validated procedure.

Time frame: From Month 3 to Month 12

Population: All randomized and transplanted participants

Arm	Measure	Group	Value (NUMBER)
Belatacept More Intensive (MI) Regimen	Percentage of Participants With a Measured Glomerular Filtration Rate (GFR) <60 mL/Min Per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/Min Per 1.73 m^2 From Month 3 to Month 12	Measured GFR <60 mL/min/1.73 m^2 (Month 12)	55.7 percentage of participants
Belatacept More Intensive (MI) Regimen	Percentage of Participants With a Measured Glomerular Filtration Rate (GFR) <60 mL/Min Per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/Min Per 1.73 m^2 From Month 3 to Month 12	GFR ≥ 10 mL/min/1.73 m^2 (Month 3 to Month 12)	17.6 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Participants With a Measured Glomerular Filtration Rate (GFR) <60 mL/Min Per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/Min Per 1.73 m^2 From Month 3 to Month 12	Measured GFR <60 mL/min/1.73 m^2 (Month 12)	62.1 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Participants With a Measured Glomerular Filtration Rate (GFR) <60 mL/Min Per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/Min Per 1.73 m^2 From Month 3 to Month 12	GFR ≥ 10 mL/min/1.73 m^2 (Month 3 to Month 12)	27.2 percentage of participants
Cyclosporin A (CsA)	Percentage of Participants With a Measured Glomerular Filtration Rate (GFR) <60 mL/Min Per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/Min Per 1.73 m^2 From Month 3 to Month 12	Measured GFR <60 mL/min/1.73 m^2 (Month 12)	67.4 percentage of participants
Cyclosporin A (CsA)	Percentage of Participants With a Measured Glomerular Filtration Rate (GFR) <60 mL/Min Per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/Min Per 1.73 m^2 From Month 3 to Month 12	GFR ≥ 10 mL/min/1.73 m^2 (Month 3 to Month 12)	24.7 percentage of participants

p-value: 0.001897.3% CI: [-24, -4.7]Chi-squared

p-value: 0.061697.3% CI: [-18, 0.9]Chi-squared

Secondary

Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months

GFR was assessed using a true measure of glomerular filtration via nonradiolabeled iothalamate clearance test using a validated procedure. Missing measured GFR assessments were imputed. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.

Time frame: Months 6, 12, 24, 36 and 84

Population: All randomized and transplanted participants

Arm	Measure	Group	Value (MEAN)	Dispersion
Belatacept More Intensive (MI) Regimen	Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months	Month 24 (n = 152,158,154)	44.4 participants	Standard Deviation 26.72
Belatacept More Intensive (MI) Regimen	Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months	Month 84 (n = 69,79,51)	57.6 participants	Standard Deviation 18.58
Belatacept More Intensive (MI) Regimen	Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months	Month 12 (n = 159,154,154)	44.4 participants	Standard Deviation 22.78
Belatacept More Intensive (MI) Regimen	Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months	Month 36 (n = 152,154,143)	42.7 participants	Standard Deviation 27.59
Belatacept More Intensive (MI) Regimen	Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months	Month 6 (n = 161,152,153)	43.6 participants	Standard Deviation 21.67
Belatacept Less Intensive (LI) Regimen	Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months	Month 12 (n = 159,154,154)	44.8 participants	Standard Deviation 21.57
Belatacept Less Intensive (LI) Regimen	Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months	Month 6 (n = 161,152,153)	43.4 participants	Standard Deviation 18.57
Belatacept Less Intensive (LI) Regimen	Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months	Month 84 (n = 69,79,51)	59.1 participants	Standard Deviation 18.85
Belatacept Less Intensive (LI) Regimen	Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months	Month 24 (n = 152,158,154)	42.8 participants	Standard Deviation 24.07
Belatacept Less Intensive (LI) Regimen	Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months	Month 36 (n = 152,154,143)	42.2 participants	Standard Deviation 25.2
Cyclosporin A (CsA)	Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months	Month 84 (n = 69,79,51)	44.6 participants	Standard Deviation 17.37
Cyclosporin A (CsA)	Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months	Month 12 (n = 159,154,154)	36.5 participants	Standard Deviation 21.08
Cyclosporin A (CsA)	Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months	Month 24 (n = 152,158,154)	34.9 participants	Standard Deviation 21.59
Cyclosporin A (CsA)	Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months	Month 6 (n = 161,152,153)	35.5 participants	Standard Deviation 20.51
Cyclosporin A (CsA)	Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months	Month 36 (n = 152,154,143)	31.5 participants	Standard Deviation 22.13

Secondary

Change in Calculated GFR at Months 12, 24, 36 and 84

Time frame: Baseline and Months 12, 24, 36 and 84

Population: All randomized and transplanted participants

Arm	Measure	Group	Value (MEAN)	Dispersion
Belatacept More Intensive (MI) Regimen	Change in Calculated GFR at Months 12, 24, 36 and 84	Month 12 (n = 159,154,154)	-0.7 mL/min/1.73 m^2	Standard Deviation 17.96
Belatacept More Intensive (MI) Regimen	Change in Calculated GFR at Months 12, 24, 36 and 84	Month 36 (n = 146,150,139)	-2.9 mL/min/1.73 m^2	Standard Deviation 23.7
Belatacept More Intensive (MI) Regimen	Change in Calculated GFR at Months 12, 24, 36 and 84	Month 84 (n = 67,76,49)	7.5 mL/min/1.73 m^2	Standard Deviation 17.48
Belatacept More Intensive (MI) Regimen	Change in Calculated GFR at Months 12, 24, 36 and 84	Month 24 (n = 146,154,149)	-1.4 mL/min/1.73 m^2	Standard Deviation 17.68
Belatacept Less Intensive (LI) Regimen	Change in Calculated GFR at Months 12, 24, 36 and 84	Month 84 (n = 67,76,49)	10.4 mL/min/1.73 m^2	Standard Deviation 17.54
Belatacept Less Intensive (LI) Regimen	Change in Calculated GFR at Months 12, 24, 36 and 84	Month 12 (n = 159,154,154)	-0.6 mL/min/1.73 m^2	Standard Deviation 15.39
Belatacept Less Intensive (LI) Regimen	Change in Calculated GFR at Months 12, 24, 36 and 84	Month 24 (n = 146,154,149)	-1.6 mL/min/1.73 m^2	Standard Deviation 18.7
Belatacept Less Intensive (LI) Regimen	Change in Calculated GFR at Months 12, 24, 36 and 84	Month 36 (n = 146,150,139)	-2.1 mL/min/1.73 m^2	Standard Deviation 20.92
Cyclosporin A (CsA)	Change in Calculated GFR at Months 12, 24, 36 and 84	Month 24 (n = 146,154,149)	-3.6 mL/min/1.73 m^2	Standard Deviation 15.37
Cyclosporin A (CsA)	Change in Calculated GFR at Months 12, 24, 36 and 84	Month 36 (n = 146,150,139)	-6.1 mL/min/1.73 m^2	Standard Deviation 17.39
Cyclosporin A (CsA)	Change in Calculated GFR at Months 12, 24, 36 and 84	Month 12 (n = 159,154,154)	-1.1 mL/min/1.73 m^2	Standard Deviation 12.48
Cyclosporin A (CsA)	Change in Calculated GFR at Months 12, 24, 36 and 84	Month 84 (n = 67,76,49)	-4.0 mL/min/1.73 m^2	Standard Deviation 17.17

Secondary

Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36

Dyslipidemia was defined as triglyceride ≥ 500 mg/dL \[5.65 mmol/L\], low density lipoprotein (LDL) ≥ 100 mg/dL \[2.59 mmol/L\], and elevated non-high density lipoprotein (HDL) ≥ 130 mg/dL \[3.36 mmol/L\]. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.

Time frame: Months 12, 24 and 36

Population: All randomized and transplanted participants

Arm	Measure	Group	Value (MEAN)	Dispersion
Belatacept More Intensive (MI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	LDL (Month 12) (n=184,175,184)	104.0 mg/dL	Standard Deviation 39.33
Belatacept More Intensive (MI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	HDL (Month 12) (n=184,175,184)	49.2 mg/dL	Standard Deviation 13.73
Belatacept More Intensive (MI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	TC (Month 24) (n=119,128,111)	175.6 mg/dL	Standard Deviation 47.99
Belatacept More Intensive (MI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	Non-HDL (Month 12) (n=184,175,184)	134.5 mg/dL	Standard Deviation 45.04
Belatacept More Intensive (MI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	Triglyceride (Month 36) (n=80,88,78)	160.7 mg/dL	Standard Deviation 98.56
Belatacept More Intensive (MI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	Non--HDL (Month 24) (n=119,128,111)	126.1 mg/dL	Standard Deviation 45.45
Belatacept More Intensive (MI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	TC (Month 12) (n =184,175,184)	183.7 mg/dL	Standard Deviation 47.72
Belatacept More Intensive (MI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	Triglyceride (Month 24) (n=98,104,93)	152.0 mg/dL	Standard Deviation 108.97
Belatacept More Intensive (MI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	Triglyceride (Month 12) (n=184,175,184)	171.9 mg/dL	Standard Deviation 129.76
Belatacept More Intensive (MI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	LDL (Month 24) (n=97,104,93)	96.9 mg/dL	Standard Deviation 33.46
Belatacept More Intensive (MI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	LDL (Month 36) (n=79,88,77)	103.1 mg/dL	Standard Deviation 32.59
Belatacept More Intensive (MI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	HDL (Month 24) (n=119,128,111)	49.5 mg/dL	Standard Deviation 16.27
Belatacept More Intensive (MI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	Non-HDL (Month 36) (n=111,117,97)	132.6 mg/dL	Standard Deviation 41.86
Belatacept More Intensive (MI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	HDL (Month 36) (n=111,117,97)	48.9 mg/dL	Standard Deviation 14.82
Belatacept More Intensive (MI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	TC (Month 36) (n=111,117,98)	181.0 mg/dL	Standard Deviation 43.84
Belatacept Less Intensive (LI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	Triglyceride (Month 36) (n=80,88,78)	154.3 mg/dL	Standard Deviation 76.58
Belatacept Less Intensive (LI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	HDL (Month 12) (n=184,175,184)	49.8 mg/dL	Standard Deviation 15.85
Belatacept Less Intensive (LI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	TC (Month 24) (n=119,128,111)	178.0 mg/dL	Standard Deviation 41.9
Belatacept Less Intensive (LI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	LDL (Month 24) (n=97,104,93)	101.4 mg/dL	Standard Deviation 36.64
Belatacept Less Intensive (LI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	Non-HDL (Month 36) (n=111,117,97)	132.2 mg/dL	Standard Deviation 46.81
Belatacept Less Intensive (LI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	TC (Month 36) (n=111,117,98)	181.9 mg/dL	Standard Deviation 49.16
Belatacept Less Intensive (LI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	LDL (Month 36) (n=79,88,77)	106.0 mg/dL	Standard Deviation 37.29
Belatacept Less Intensive (LI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	Non-HDL (Month 12) (n=184,175,184)	134.2 mg/dL	Standard Deviation 40.69
Belatacept Less Intensive (LI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	TC (Month 12) (n =184,175,184)	184.1 mg/dL	Standard Deviation 45.51
Belatacept Less Intensive (LI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	LDL (Month 12) (n=184,175,184)	102.4 mg/dL	Standard Deviation 36.63
Belatacept Less Intensive (LI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	Non--HDL (Month 24) (n=119,128,111)	129.8 mg/dL	Standard Deviation 37.89
Belatacept Less Intensive (LI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	Triglyceride (Month 24) (n=98,104,93)	147.0 mg/dL	Standard Deviation 69.45
Belatacept Less Intensive (LI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	HDL (Month 24) (n=119,128,111)	48.2 mg/dL	Standard Deviation 14.41
Belatacept Less Intensive (LI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	Triglyceride (Month 12) (n=184,175,184)	153.2 mg/dL	Standard Deviation 69.92
Belatacept Less Intensive (LI) Regimen	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	HDL (Month 36) (n=111,117,97)	49.6 mg/dL	Standard Deviation 16.24
Cyclosporin A (CsA)	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	LDL (Month 36) (n=79,88,77)	102.3 mg/dL	Standard Deviation 47.4
Cyclosporin A (CsA)	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	HDL (Month 12) (n=184,175,184)	47.9 mg/dL	Standard Deviation 14.76
Cyclosporin A (CsA)	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	Triglyceride (Month 24) (n=98,104,93)	208.2 mg/dL	Standard Deviation 135.19
Cyclosporin A (CsA)	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	LDL (Month 24) (n=97,104,93)	108.6 mg/dL	Standard Deviation 40.8
Cyclosporin A (CsA)	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	Triglyceride (Month 12) (n=184,175,184)	213.8 mg/dL	Standard Deviation 113.12
Cyclosporin A (CsA)	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	HDL (Month 24) (n=119,128,111)	47.0 mg/dL	Standard Deviation 17.77
Cyclosporin A (CsA)	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	Non-HDL (Month 36) (n=111,117,97)	139.1 mg/dL	Standard Deviation 49.68
Cyclosporin A (CsA)	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	TC (Month 36) (n=111,117,98)	196.7 mg/dL	Standard Deviation 127.35
Cyclosporin A (CsA)	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	TC (Month 24) (n=119,128,111)	195.7 mg/dL	Standard Deviation 61.46
Cyclosporin A (CsA)	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	TC (Month 12) (n =184,175,184)	201.3 mg/dL	Standard Deviation 49.49
Cyclosporin A (CsA)	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	HDL (Month 36) (n=111,117,97)	47.0 mg/dL	Standard Deviation 14.28
Cyclosporin A (CsA)	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	LDL (Month 12) (n=184,175,184)	107.8 mg/dL	Standard Deviation 40.08
Cyclosporin A (CsA)	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	Non-HDL (Month 12) (n=184,175,184)	153.4 mg/dL	Standard Deviation 46.99
Cyclosporin A (CsA)	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	Triglyceride (Month 36) (n=80,88,78)	181.3 mg/dL	Standard Deviation 108.32
Cyclosporin A (CsA)	Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36	Non--HDL (Month 24) (n=119,128,111)	148.7 mg/dL	Standard Deviation 60.46

Secondary

Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36

The SF-36 is a 36-item self-administered questionnaire developed to assess health-related quality of life (QOL) and comprises 8 domains, including 4 physical (physical health, bodily pain, physical functioning and physical role limitations) and 4 mental (mental health, vitality, social functioning, and emotional role limitation) subscales. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QOL (0=Poorest Health; 100=Best Health). Mean change from baseline = post-baseline value - baseline value; a higher value signifies improvement.

Time frame: Baseline and Months 12, 24 and 36

Population: Randomized and transplanted participants

Arm	Measure	Group	Value (MEAN)	Dispersion
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Vitality (Month 36)	4.1 units on SF-36 scale	Standard Error 0.837
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Role-physical (Month 24)	5.3 units on SF-36 scale	Standard Error 0.845
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Vitality (Month 24)	3.9 units on SF-36 scale	Standard Error 0.813
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	General health (Month 12)	2.9 units on SF-36 scale	Standard Error 0.747
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Physical functioning (Month 24)	1.5 units on SF-36 scale	Standard Error 0.826
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Social functioning (Month 24)	3.2 units on SF-36 scale	Standard Error 0.824
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Mental health (Month 36)	3.6 units on SF-36 scale	Standard Error 0.855
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Mental health (Month 12)	2.7 units on SF-36 scale	Standard Error 0.909
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	General health (Month 36)	2.1 units on SF-36 scale	Standard Error 0.785
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Physical functioning (Month 12)	2.1 units on SF-36 scale	Standard Error 0.849
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Vitality (Month 12)	4.1 units on SF-36 scale	Standard Error 0.845
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Role-emotional (Month 36)	2.2 units on SF-36 scale	Standard Error 1.003
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Social functioning (Month 36)	2.9 units on SF-36 scale	Standard Error 0.847
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Bodily pain (Month 36)	1.6 units on SF-36 scale	Standard Error 0.899
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Social functioning (Month 12)	4.2 units on SF-36 scale	Standard Error 0.863
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Role-physical (Month 36)	5.7 units on SF-36 scale	Standard Error 0.868
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Role-emotional (Month 12)	2.0 units on SF-36 scale	Standard Error 1.049
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Bodily pain (Month 12)	2.9 units on SF-36 scale	Standard Error 0.925
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Physical functioning (Month 36)	1.3 units on SF-36 scale	Standard Error 0.893
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Mental health (Month 24)	3.0 units on SF-36 scale	Standard Error 0.883
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Bodily pain (Month 24)	2.0 units on SF-36 scale	Standard Error 0.915
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Role-physical (Month 12)	5.2 units on SF-36 scale	Standard Error 0.912
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Role-emotional (Month 24)	2.5 units on SF-36 scale	Standard Error 0.99
Belatacept More Intensive (MI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	General health (Month 24)	2.6 units on SF-36 scale	Standard Error 0.749
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Role-physical (Month 24)	6.1 units on SF-36 scale	Standard Error 0.83
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Role-physical (Month 12)	6.2 units on SF-36 scale	Standard Error 0.883
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Bodily pain (Month 12)	0.9 units on SF-36 scale	Standard Error 0.887
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	General health (Month 12)	2.4 units on SF-36 scale	Standard Error 0.722
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Vitality (Month 12)	3.6 units on SF-36 scale	Standard Error 0.814
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Role-emotional (Month 12)	2.4 units on SF-36 scale	Standard Error 1.019
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Bodily pain (Month 24)	0.0 units on SF-36 scale	Standard Error 0.891
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	General health (Month 24)	2.0 units on SF-36 scale	Standard Error 0.737
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Vitality (Month 24)	3.1 units on SF-36 scale	Standard Error 0.801
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Social functioning (Month 24)	5.0 units on SF-36 scale	Standard Error 0.807
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Role-emotional (Month 24)	3.0 units on SF-36 scale	Standard Error 0.972
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Social functioning (Month 36)	4.6 units on SF-36 scale	Standard Error 0.83
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Social functioning (Month 12)	3.5 units on SF-36 scale	Standard Error 0.83
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Mental health (Month 12)	1.7 units on SF-36 scale	Standard Error 0.875
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Physical functioning (Month 24)	3.5 units on SF-36 scale	Standard Error 0.81
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Physical functioning (Month 12)	3.6 units on SF-36 scale	Standard Error 0.82
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Mental health (Month 24)	1.9 units on SF-36 scale	Standard Error 0.869
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Physical functioning (Month 36)	3.0 units on SF-36 scale	Standard Error 0.872
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Role-physical (Month 36)	5.8 units on SF-36 scale	Standard Error 0.856
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Bodily pain (Month 36)	0.3 units on SF-36 scale	Standard Error 0.875
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	General health (Month 36)	0.9 units on SF-36 scale	Standard Error 0.773
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Vitality (Month 36)	2.5 units on SF-36 scale	Standard Error 0.823
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Role-emotional (Month 36)	2.4 units on SF-36 scale	Standard Error 0.992
Belatacept Less Intensive (LI) Regimen	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Mental health (Month 36)	0.7 units on SF-36 scale	Standard Error 0.841
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Vitality (Month 36)	1.4 units on SF-36 scale	Standard Error 0.813
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Mental health (Month 24)	1.4 units on SF-36 scale	Standard Error 0.861
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Role-emotional (Month 12)	3.5 units on SF-36 scale	Standard Error 1.026
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Role-physical (Month 12)	4.7 units on SF-36 scale	Standard Error 0.877
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Physical functioning (Month 36)	0.7 units on SF-36 scale	Standard Error 0.866
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Social functioning (Month 12)	2.1 units on SF-36 scale	Standard Error 0.827
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Social functioning (Month 36)	1.4 units on SF-36 scale	Standard Error 0.825
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Role-physical (Month 36)	4.1 units on SF-36 scale	Standard Error 0.844
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Vitality (Month 12)	2.9 units on SF-36 scale	Standard Error 0.808
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Mental health (Month 36)	0.9 units on SF-36 scale	Standard Error 0.83
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Bodily pain (Month 36)	-2.2 units on SF-36 scale	Standard Error 0.869
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	General health (Month 12)	2.1 units on SF-36 scale	Standard Error 0.719
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Role-emotional (Month 24)	2.9 units on SF-36 scale	Standard Error 0.979
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Role-emotional (Month 36)	2.5 units on SF-36 scale	Standard Error 0.988
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Social functioning (Month 24)	2.1 units on SF-36 scale	Standard Error 0.805
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	General health (Month 36)	-0.5 units on SF-36 scale	Standard Error 0.768
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Mental health (Month 12)	2.4 units on SF-36 scale	Standard Error 0.869
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Vitality (Month 24)	1.4 units on SF-36 scale	Standard Error 0.793
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Bodily pain (Month 12)	-0.7 units on SF-36 scale	Standard Error 0.89
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Physical functioning (Month 24)	0.7 units on SF-36 scale	Standard Error 0.804
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	General health (Month 24)	0.6 units on SF-36 scale	Standard Error 0.732
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Physical functioning (Month 12)	1.9 units on SF-36 scale	Standard Error 0.814
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Bodily pain (Month 24)	-1.9 units on SF-36 scale	Standard Error 0.891
Cyclosporin A (CsA)	Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36	Role-physical (Month 24)	4.3 units on SF-36 scale	Standard Error 0.827

Secondary

Mean Framingham Risk Score From Baseline to Months 12, 24 and 36

The risk score was calculated based on the total points from six variables: Age, Level of LDL-cholesterol, Level of HDL-cholesterol, Presence and severity of systolic or diastolic hypertension, Presence or absence of a history of diabetes mellitus and Presence or absence of a history recent cigarette smoking. Total scores can range from \<-3 to \>14, which translate to a 1% to 56% risk of developing coronary heart disease in 10 years. Totals in the 4 to 6 point range translate to a 7 to 11% risk and 8 to 10 point range translate to a 18 to 27% risk.

Time frame: Baseline and Months 12, 24 and 36

Population: All randomized and transplanted participants

Arm	Measure	Group	Value (MEAN)	Dispersion
Belatacept More Intensive (MI) Regimen	Mean Framingham Risk Score From Baseline to Months 12, 24 and 36	Month 24	5.0 units on a scale	Standard Deviation 4.25
Belatacept More Intensive (MI) Regimen	Mean Framingham Risk Score From Baseline to Months 12, 24 and 36	Month 12	5.3 units on a scale	Standard Deviation 4.11
Belatacept More Intensive (MI) Regimen	Mean Framingham Risk Score From Baseline to Months 12, 24 and 36	Month 36	5.2 units on a scale	Standard Deviation 4.18
Belatacept Less Intensive (LI) Regimen	Mean Framingham Risk Score From Baseline to Months 12, 24 and 36	Month 24	4.6 units on a scale	Standard Deviation 4.23
Belatacept Less Intensive (LI) Regimen	Mean Framingham Risk Score From Baseline to Months 12, 24 and 36	Month 12	4.5 units on a scale	Standard Deviation 4.02
Belatacept Less Intensive (LI) Regimen	Mean Framingham Risk Score From Baseline to Months 12, 24 and 36	Month 36	4.9 units on a scale	Standard Deviation 3.84
Cyclosporin A (CsA)	Mean Framingham Risk Score From Baseline to Months 12, 24 and 36	Month 12	6.0 units on a scale	Standard Deviation 3.98
Cyclosporin A (CsA)	Mean Framingham Risk Score From Baseline to Months 12, 24 and 36	Month 36	5.8 units on a scale	Standard Deviation 4
Cyclosporin A (CsA)	Mean Framingham Risk Score From Baseline to Months 12, 24 and 36	Month 24	6.2 units on a scale	Standard Deviation 4.07

Secondary

Measured Glomerular Filtration Rate (GFR) by Month 12 and 24

GFR was assessed using a true measure of glomerular filtration via nonradiolabeled iothalamate clearance test using a validated procedure. Missing measured GFR assessments were imputed. Here, 'n' signifies the number of evaluable participants for the reporting arm at the given time point. Missing measured GFR assessments were imputed to a GFR of zero.

Time frame: At Month 12 and Month 24

Population: All randomized and transplanted participants

Arm	Measure	Group	Value (MEAN)	Dispersion
Belatacept More Intensive (MI) Regimen	Measured Glomerular Filtration Rate (GFR) by Month 12 and 24	Month 12 (n = 154,151,154)	52.1 mL/min/1.73 m^2	Standard Deviation 21.9
Belatacept More Intensive (MI) Regimen	Measured Glomerular Filtration Rate (GFR) by Month 12 and 24	Month 24 (n = 136,139,136)	51.5 mL/min/1.73 m^2	Standard Deviation 22.9
Belatacept Less Intensive (LI) Regimen	Measured Glomerular Filtration Rate (GFR) by Month 12 and 24	Month 12 (n = 154,151,154)	49.5 mL/min/1.73 m^2	Standard Deviation 25.4
Belatacept Less Intensive (LI) Regimen	Measured Glomerular Filtration Rate (GFR) by Month 12 and 24	Month 24 (n = 136,139,136)	49.7 mL/min/1.73 m^2	Standard Deviation 23.67
Cyclosporin A (CsA)	Measured Glomerular Filtration Rate (GFR) by Month 12 and 24	Month 12 (n = 154,151,154)	45.2 mL/min/1.73 m^2	Standard Deviation 21.1
Cyclosporin A (CsA)	Measured Glomerular Filtration Rate (GFR) by Month 12 and 24	Month 24 (n = 136,139,136)	45.0 mL/min/1.73 m^2	Standard Deviation 27.18

Secondary

Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84

Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Clinically suspected acute rejection was defined as an unexplained rise of serum creatinine ≥ 25% from baseline creatinine or an unexplained decreased urine output or fever and graft tenderness or serum creatinine that remains elevated within 14 days post--transplantation and clinical suspicion of acute rejection exists.

Time frame: Months 6, 12, 24, 36 and 84

Population: All randomized and transplanted participants

Arm	Measure	Group	Value (NUMBER)
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Severe acute (III) (Month 6)	0 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IA) (Month 84)	0 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IA) (Month 24)	0 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IB) (Month 6)	6 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Severe acute (III) (Month 36)	1 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IB) (Month 24)	6 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IIA) (Month 36)	10 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IIB) (Month 36)	16 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IIA) (Month 24)	10 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IA) (Month 6)	0 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Severe acute (III) (Month 24)	0 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IB) (Month 24)	16 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IA) (Month 12)	0 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IB) (Month 36)	6 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Severe acute (III) (Month 84)	1 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IB) (Month 12)	6 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IB) (Month 6)	15 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IIB) (Month 84)	16 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IIA) (Month 12)	11 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IIA) (Month 6)	11 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IIA) (Month 84)	12 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IB) (Month 12)	15 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IA) (Month 36)	0 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IB) (Month 84)	6 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Severe acute (III) (Month 12)	0 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IA) (Month 24)	4 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IB) (Month 6)	2 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IIA) (Month 6)	15 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IB) (Month 6)	8 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Severe acute (III) (Month 6)	0 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IA) (Month 12)	4 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IB) (Month 12)	2 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IIA) (Month 12)	17 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IB) (Month 12)	8 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Severe acute (III) (Month 12)	0 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IB) (Month 24)	2 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IIA) (Month 24)	17 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IB) (Month 24)	9 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IIB) (Month 36)	9 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Severe acute (III) (Month 36)	0 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IA) (Month 84)	4 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IB) (Month 84)	6 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IIA) (Month 84)	18 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IIB) (Month 84)	9 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Severe acute (III) (Month 84)	0 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IA) (Month 6)	4 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Severe acute (III) (Month 24)	0 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IA) (Month 36)	4 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IB) (Month 36)	2 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IIA) (Month 36)	18 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IB) (Month 12)	5 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IB) (Month 6)	5 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IB) (Month 84)	4 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IIA) (Month 12)	17 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IB) (Month 6)	2 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IIA) (Month 84)	18 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IB) (Month 12)	2 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IA) (Month 36)	2 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IA) (Month 12)	2 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IIA) (Month 6)	16 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Severe acute (III) (Month 84)	0 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Severe acute (III) (Month 6)	0 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IIB) (Month 84)	5 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IB) (Month 24)	5 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IIA) (Month 24)	18 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IIA) (Month 36)	18 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IB) (Month 24)	3 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IA) (Month 6)	2 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Moderate acute (IIB) (Month 36)	5 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IA) (Month 24)	2 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IB) (Month 36)	4 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Severe acute (III) (Month 36)	0 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Severe acute (III) (Month 12)	0 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Severe acute (III) (Month 24)	0 participants
Cyclosporin A (CsA)	Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84	Mild acute (IA) (Month 84)	2 participants

Secondary

Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.

Acute rejection was defined as central biopsy proven rejection that was either clinically suspected by protocol defined reasons or clinically suspected by other reasons and treated. Lymphocyte -depletion therapy for treatment of an episode of acute was defined as a participant treated with therapy and provided not treated with steroids earlier while steroid resistant acute rejection was defined as participants initially treated with steroids alone for suspected acute rejection for at least 2 days and then followed by the start of lymphocyte -depletion therapy.

Time frame: Months 6, 12, 24 and 36

Population: All randomized and transplanted participants

Arm	Measure	Group	Value (NUMBER)
Belatacept More Intensive (MI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Only corticosteroid treated (Month 6)	14 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Corticosteroid resistant (Month 6)	2 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Lymphocyte-depleting treated (Month 6)	13 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Only corticosteroid treated (Month 12)	14 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Corticosteroid resistant (Month 12)	2 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Lymphocyte-depleting treated (Month 12)	13 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Lymphocyte-depleting treated (Month 24)	14 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Only corticosteroid treated (Month 36)	13 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Corticosteroid resistant (Month 36)	2 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Lymphocyte-depleting treated (Month 36)	14 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Only corticosteroid treated (Month 24)	13 participants
Belatacept More Intensive (MI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Corticosteroid resistant (Month 24)	2 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Lymphocyte-depleting treated (Month 36)	7 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Only corticosteroid treated (Month 6)	16 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Lymphocyte-depleting treated (Month 24)	7 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Corticosteroid resistant (Month 36)	1 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Corticosteroid resistant (Month 6)	2 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Lymphocyte-depleting treated (Month 12)	5 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Corticosteroid resistant (Month 12)	2 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Lymphocyte-depleting treated (Month 6)	5 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Only corticosteroid treated (Month 36)	19 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Corticosteroid resistant (Month 24)	1 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Only corticosteroid treated (Month 12)	16 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Only corticosteroid treated (Month 24)	19 participants
Cyclosporin A (CsA)	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Only corticosteroid treated (Month 12)	10 participants
Cyclosporin A (CsA)	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Corticosteroid resistant (Month 12)	2 participants
Cyclosporin A (CsA)	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Corticosteroid resistant (Month 24)	2 participants
Cyclosporin A (CsA)	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Lymphocyte-depleting treated (Month 12)	4 participants
Cyclosporin A (CsA)	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Lymphocyte-depleting treated (Month 24)	4 participants
Cyclosporin A (CsA)	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Only corticosteroid treated (Month 24)	11 participants
Cyclosporin A (CsA)	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Only corticosteroid treated (Month 36)	11 participants
Cyclosporin A (CsA)	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Only corticosteroid treated (Month 6)	9 participants
Cyclosporin A (CsA)	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Corticosteroid resistant (Month 6)	2 participants
Cyclosporin A (CsA)	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Corticosteroid resistant (Month 36)	2 participants
Cyclosporin A (CsA)	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Lymphocyte-depleting treated (Month 6)	4 participants
Cyclosporin A (CsA)	Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.	Lymphocyte-depleting treated (Month 36)	4 participants

Secondary

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36

AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

Time frame: Day 1 to Month 36

Population: All randomized and transplanted participants

Arm	Measure	Group	Value (NUMBER)
Belatacept More Intensive (MI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	SAEs leading to Discontinuation	31 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	Related SAEs	60 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	Deaths	22 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	SAEs	149 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	Related AEs	115 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	AEs leading to Discontinuation	34 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	AEs	182 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	SAEs leading to Discontinuation	31 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	AEs	174 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	SAEs	139 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	Related SAEs	51 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	AEs leading to Discontinuation	36 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	Deaths	15 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	Related AEs	106 participants
Cyclosporin A (CsA)	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	Deaths	17 participants
Cyclosporin A (CsA)	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	Related SAEs	58 participants
Cyclosporin A (CsA)	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	AEs	184 participants
Cyclosporin A (CsA)	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	SAEs	146 participants
Cyclosporin A (CsA)	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	AEs leading to Discontinuation	44 participants
Cyclosporin A (CsA)	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	Related AEs	141 participants
Cyclosporin A (CsA)	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36	SAEs leading to Discontinuation	28 participants

Secondary

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84

Time frame: Day 1 to Month 84

Population: All randomized and transplanted participants who completed 36 months of treatment and continued into long-term extension phase

Arm	Measure	Group	Value (NUMBER)
Belatacept More Intensive (MI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84	SAEs	94 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84	AEs leading to Discontinuation	14 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84	AEs	104 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84	Deaths	14 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84	SAEs leading to Discontinuation	94 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84	SAEs	104 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84	AEs	113 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84	AEs leading to Discontinuation	14 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84	SAEs leading to Discontinuation	104 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84	Deaths	21 participants
Cyclosporin A (CsA)	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84	Deaths	9 participants
Cyclosporin A (CsA)	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84	SAEs leading to Discontinuation	7 participants
Cyclosporin A (CsA)	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84	SAEs	73 participants
Cyclosporin A (CsA)	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84	AEs leading to Discontinuation	7 participants
Cyclosporin A (CsA)	Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84	AEs	87 participants

Secondary

Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months

Participants were determined to have hypertension at a particular time point if standardized systolic blood pressure ≥ 130 mm Hg or standardized diastolic blood pressure ≥ 80 mm Hg or participant had received an antihypertensive medication(s) for hypertension. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.

Time frame: Baseline and Months 12, 24 and 36

Population: All randomized and transplanted participants

Arm	Measure	Group	Value (NUMBER)
Belatacept More Intensive (MI) Regimen	Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months	1-2 Medications at Month 12 (n=184,175,184)	82 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months	≥ 3 Medications at Month 12 (n=184,175,184)	76 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months	1-2 Medications at Month 36 (n=151,145,143)	65 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months	1-2 Medications at Month 24 (n=177,170,179)	80 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months	≥ 3 Medications at Month 24 (n=177,170,179)	78 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months	≥ 3 Medications at Month 36 (n=151,145,143)	70 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months	≥ 3 Medications at Month 24 (n=177,170,179)	65 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months	≥ 3 Medications at Month 36 (n=151,145,143)	60 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months	1-2 Medications at Month 36 (n=151,145,143)	67 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months	1-2 Medications at Month 24 (n=177,170,179)	79 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months	1-2 Medications at Month 12 (n=184,175,184)	79 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months	≥ 3 Medications at Month 12 (n=184,175,184)	66 participants
Cyclosporin A (CsA)	Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months	1-2 Medications at Month 24 (n=177,170,179)	71 participants
Cyclosporin A (CsA)	Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months	≥ 3 Medications at Month 24 (n=177,170,179)	89 participants
Cyclosporin A (CsA)	Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months	1-2 Medications at Month 36 (n=151,145,143)	51 participants
Cyclosporin A (CsA)	Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months	≥ 3 Medications at Month 12 (n=184,175,184)	93 participants
Cyclosporin A (CsA)	Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months	≥ 3 Medications at Month 36 (n=151,145,143)	79 participants
Cyclosporin A (CsA)	Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months	1-2 Medications at Month 12 (n=184,175,184)	76 participants

Secondary

Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months

Participants with abnormal blood pressure, body weight and body temperature outside the defined normal range were graded as clinically significant vital signs by the investigator.

Time frame: Day 1 to Month 36

Population: All randomized and transplanted participants

Arm	Measure	Group	Value (NUMBER)
Belatacept More Intensive (MI) Regimen	Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months	Heart Rate	0 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months	Body Temperature	0 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months	Body Weight	0 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months	Heart Rate	0 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months	Body Temperature	0 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months	Body Weight	0 participants
Cyclosporin A (CsA)	Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months	Heart Rate	0 participants
Cyclosporin A (CsA)	Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months	Body Temperature	0 participants
Cyclosporin A (CsA)	Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months	Body Weight	0 participants

Secondary

Number of Participants With Laboratory Test Abnormalities up to 36 Months

Participants with laboratory values outside the defined normal range were graded as clinically significant laboratory abnormalities by the investigator. Subjects were analyzed for Alkaline phosphatase (ALP), Alanine aminotransferase (ALT), Aspartate aminotransferase(AST), Hemoglobin, Platelet Count, Leukocytes, Bilirubin, Creatinine, Calcium, Bicarbonate, Potassium, Magnesium, Sodium, Phosphorus, Albumin, Uric Acid and Protein. Laboratory abnormalities were assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3. Here 'n' signifies those subjects evaluable for this measure at specified time points for each arm, respectively.

Time frame: Day 1 to Month 36

Population: All randomized and transplanted participants.

Arm	Measure	Group	Value (NUMBER)
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Uric Acid (High) (n=177,172,182)	31 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Bicarbonate (High) (n=176,171,181)	0 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Bilirubin, Total (High) (n=177,172,182)	0 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Magnesium, Serum (Low)(n=177,172,181)	6 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Bicarbonate (Low) (n=176,171,181)	2 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Creatinine (High) (n=177,172,182)	125 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Albumin (Low) (n=177,172,182)	2 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Calcium, Total (High) (n=177,172,182)	2 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Calcium, Total (Low) (n=177,172,182)	19 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Phosphorus (Low) (n=177,172,182)	66 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Platelet Count (Low) (n=177,172,181)	2 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	ALP (High) (n=177,172,182)	1 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Sodium, Serum (High)(n=177,172,181)	0 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Leukocytes (Low) (n=177,172,181)	10 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Potassium, Serum (Low)(n=177,172,181)	6 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Sodium, Serum (Low)(n=177,172,181)	18 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Hemoglobin (Low) (n=177,172,181)	25 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Magnesium, Serum (High)(n=177,172,181)	6 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	ALT (High) (n=177,172,181)	4 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Protein, Urine (High) (n=173,168,177)	44 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Potassium, Serum (High)(n=177,172,181)	8 participants
Belatacept More Intensive (MI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	AST (High) (n=177,172,181)	1 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	ALP (High) (n=177,172,182)	1 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Hemoglobin (Low) (n=177,172,181)	24 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Potassium, Serum (High)(n=177,172,181)	6 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Platelet Count (Low) (n=177,172,181)	1 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Leukocytes (Low) (n=177,172,181)	5 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	ALT (High) (n=177,172,181)	2 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	AST (High) (n=177,172,181)	1 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Bilirubin, Total (High) (n=177,172,182)	2 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Creatinine (High) (n=177,172,182)	117 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Calcium, Total (Low) (n=177,172,182)	14 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Calcium, Total (High) (n=177,172,182)	2 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Bicarbonate (Low) (n=176,171,181)	1 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Bicarbonate (High) (n=176,171,181)	0 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Potassium, Serum (Low)(n=177,172,181)	3 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Magnesium, Serum (Low)(n=177,172,181)	3 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Magnesium, Serum (High)(n=177,172,181)	4 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Sodium, Serum (Low)(n=177,172,181)	16 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Sodium, Serum (High)(n=177,172,181)	0 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Phosphorus (Low) (n=177,172,182)	58 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Albumin (Low) (n=177,172,182)	4 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Uric Acid (High) (n=177,172,182)	34 participants
Belatacept Less Intensive (LI) Regimen	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Protein, Urine (High) (n=173,168,177)	37 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	ALT (High) (n=177,172,181)	4 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Magnesium, Serum (High)(n=177,172,181)	9 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Magnesium, Serum (Low)(n=177,172,181)	1 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	ALP (High) (n=177,172,182)	0 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Hemoglobin (Low) (n=177,172,181)	16 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Leukocytes (Low) (n=177,172,181)	8 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Albumin (Low) (n=177,172,182)	1 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Sodium, Serum (Low)(n=177,172,181)	23 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Platelet Count (Low) (n=177,172,181)	2 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Potassium, Serum (High)(n=177,172,181)	11 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Calcium, Total (Low) (n=177,172,182)	10 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Creatinine (High) (n=177,172,182)	128 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Sodium, Serum (High)(n=177,172,181)	1 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Calcium, Total (High) (n=177,172,182)	1 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Bilirubin, Total (High) (n=177,172,182)	1 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Uric Acid (High) (n=177,172,182)	60 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Bicarbonate (Low) (n=176,171,181)	2 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	AST (High) (n=177,172,181)	0 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Protein, Urine (High) (n=173,168,177)	43 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Bicarbonate (High) (n=176,171,181)	0 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Phosphorus (Low) (n=177,172,182)	44 participants
Cyclosporin A (CsA)	Number of Participants With Laboratory Test Abnormalities up to 36 Months	Potassium, Serum (Low)(n=177,172,181)	9 participants

Secondary

Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months

Dyslipidemia was defined as triglyceride ≥ 500 mg/dL \[5.65 mmol/L\], low density lipoprotein (LDL) ≥ 100 mg/dL \[2.59 mmol/L\], and non-elevated high density lipoprotein (HDL) ≥ 130 mg/dL \[3.36 mmol/L\]. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.

Time frame: Months 12, 24 and 36

Population: All randomized and transplanted participants

Arm	Measure	Group	Value (NUMBER)
Belatacept More Intensive (MI) Regimen	Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months	Month 12 (n=184.175,184)	43.5 percentage of participants
Belatacept More Intensive (MI) Regimen	Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months	Month 36 (n=151,145,143)	52.3 percentage of participants
Belatacept More Intensive (MI) Regimen	Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months	Month 24 (n=184,175,184)	47.8 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months	Month 12 (n=184.175,184)	40.0 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months	Month 36 (n=151,145,143)	45.5 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months	Month 24 (n=184,175,184)	42.3 percentage of participants
Cyclosporin A (CsA)	Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months	Month 36 (n=151,145,143)	60.8 percentage of participants
Cyclosporin A (CsA)	Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months	Month 24 (n=184,175,184)	51.1 percentage of participants
Cyclosporin A (CsA)	Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months	Month 12 (n=184.175,184)	46.2 percentage of participants

Secondary

Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84

Time frame: Months 6, 12, 24, 36 and 84

Population: All randomized and transplanted participants

Arm	Measure	Group	Value (NUMBER)
Belatacept More Intensive (MI) Regimen	Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84	Month 6	17.4 percentage of participants
Belatacept More Intensive (MI) Regimen	Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84	Month 24	17.4 percentage of participants
Belatacept More Intensive (MI) Regimen	Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84	Month 12	17.4 percentage of participants
Belatacept More Intensive (MI) Regimen	Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84	Month 36	17.9 percentage of participants
Belatacept More Intensive (MI) Regimen	Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84	Month 84	19.0 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84	Month 36	18.9 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84	Month 6	16.6 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84	Month 84	19.4 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84	Month 12	17.7 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84	Month 24	18.3 percentage of participants
Cyclosporin A (CsA)	Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84	Month 84	15.8 percentage of participants
Cyclosporin A (CsA)	Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84	Month 12	14.1 percentage of participants
Cyclosporin A (CsA)	Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84	Month 24	15.2 percentage of participants
Cyclosporin A (CsA)	Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84	Month 6	13.6 percentage of participants
Cyclosporin A (CsA)	Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84	Month 36	15.8 percentage of participants

Secondary

Percentage of Participants Who Survived With a Graft at 24 and 36 Months Post-Transplant

Participant and graft survival at 12 months was summarized within each treatment group. Graft loss was defined as either functional loss or physical loss (nephrectomy). Functional loss will be defined as a sustained level of serum creatinine ≥ 6.0 mg/dL (530 μmol/L) as determined by central laboratory for ≥ 4 weeks or 56 or more consecutive days of dialysis.

Time frame: Month 24 and Month 36 post-transplant

Population: All randomized and transplanted participants

Arm	Measure	Group	Value (NUMBER)
Belatacept More Intensive (MI) Regimen	Percentage of Participants Who Survived With a Graft at 24 and 36 Months Post-Transplant	Month 24	82.6 percentage of participants
Belatacept More Intensive (MI) Regimen	Percentage of Participants Who Survived With a Graft at 24 and 36 Months Post-Transplant	Month 36	80.4 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Participants Who Survived With a Graft at 24 and 36 Months Post-Transplant	Month 24	84.0 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Participants Who Survived With a Graft at 24 and 36 Months Post-Transplant	Month 36	82.3 percentage of participants
Cyclosporin A (CsA)	Percentage of Participants Who Survived With a Graft at 24 and 36 Months Post-Transplant	Month 24	82.6 percentage of participants
Cyclosporin A (CsA)	Percentage of Participants Who Survived With a Graft at 24 and 36 Months Post-Transplant	Month 36	79.9 percentage of participants

Secondary

Percentage of Participants With Chronic Allograft Nephropathy (CAN) at Month 12

Biopsy-proven CAN was determined by a blinded central histopathologist using the Banff 97 working classification of kidney transplant pathology. Onset of CAN was determined by the biopsy date when it was observed. Participants were considered as having CAN at 12 months if: CAN observed in a biopsy either prior to 12 months (including baseline biopsy) or first post 12 months biopsy; Participant had graft loss during the first year post transplant; no biopsy available post 12 months and CAN not observed in biopsies prior to 12 months; no biopsy available either prior to or post 12 months; and the measured glomerular filtration rate from Month 3 to Month 12 decreases at least 10 mL/min/1.73m\^2. All other participants with missing 12 month biopsy were considered having no CAN observed at 12 months.

Time frame: At Month 12

Population: All randomized and transplanted participants

Arm	Measure	Value (NUMBER)
Belatacept More Intensive (MI) Regimen	Percentage of Participants With Chronic Allograft Nephropathy (CAN) at Month 12	44.8 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Participants With Chronic Allograft Nephropathy (CAN) at Month 12	46.0 percentage of participants
Cyclosporin A (CsA)	Percentage of Participants With Chronic Allograft Nephropathy (CAN) at Month 12	51.6 percentage of participants

Secondary

Percentage of Participants With Graft Loss or Death to Month 84

Participant and graft survival at 84 months was summarized within each treatment group.

Time frame: Randomization to date of death, up to 84 months

Population: All randomized and transplanted participants

Arm	Measure	Group	Value (NUMBER)
Belatacept More Intensive (MI) Regimen	Percentage of Participants With Graft Loss or Death to Month 84	Graft Loss or Death	29.3 percentage of participants
Belatacept More Intensive (MI) Regimen	Percentage of Participants With Graft Loss or Death to Month 84	Death	20.1 percentage of participants
Belatacept More Intensive (MI) Regimen	Percentage of Participants With Graft Loss or Death to Month 84	Death with Functioning Graft	17.9 percentage of participants
Belatacept More Intensive (MI) Regimen	Percentage of Participants With Graft Loss or Death to Month 84	Graft Loss	11.4 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Participants With Graft Loss or Death to Month 84	Graft Loss or Death	30.9 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Participants With Graft Loss or Death to Month 84	Graft Loss	13.1 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Participants With Graft Loss or Death to Month 84	Death	21.1 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Participants With Graft Loss or Death to Month 84	Death with Functioning Graft	17.7 percentage of participants
Cyclosporin A (CsA)	Percentage of Participants With Graft Loss or Death to Month 84	Death	15.8 percentage of participants
Cyclosporin A (CsA)	Percentage of Participants With Graft Loss or Death to Month 84	Graft Loss or Death	28.3 percentage of participants
Cyclosporin A (CsA)	Percentage of Participants With Graft Loss or Death to Month 84	Graft Loss	15.8 percentage of participants
Cyclosporin A (CsA)	Percentage of Participants With Graft Loss or Death to Month 84	Death with Functioning Graft	12.5 percentage of participants

Secondary

Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.

NODM was defined as participant who did not have diabetes prior to randomization. Participants were determined for NODM if the participant received an antidiabetic medication for a duration of at least 30 days, or at least two fasting plasma glucose (FPG) tests indicate that FPG is ≥ 126 mg/dL (7.0 mmol/L).

Time frame: Months 12, 24 and 36

Population: All randomized and transplanted participants

Arm	Measure	Group	Value (NUMBER)
Belatacept More Intensive (MI) Regimen	Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.	36 Month	5.3 percentage of participants
Belatacept More Intensive (MI) Regimen	Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.	24 Month	3.0 percentage of participants
Belatacept More Intensive (MI) Regimen	Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.	12 Month	2.3 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.	36 Month	9.6 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.	12 Month	5.1 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.	24 Month	7.4 percentage of participants
Cyclosporin A (CsA)	Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.	36 Month	9.3 percentage of participants
Cyclosporin A (CsA)	Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.	24 Month	9.3 percentage of participants
Cyclosporin A (CsA)	Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.	12 Month	9.3 percentage of participants

Secondary

Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36

Participants were determined to have hypertension at a particular time point if standardized systolic blood pressure ≥ 130 mm Hg or standardized diastolic blood pressure ≥ 80 mm Hg or subject had received an anti-hypertensive medication(s) for hypertension. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.

Time frame: Months 12, 24 and 36

Population: All randomized and transplanted participants

Arm	Measure	Group	Value (NUMBER)
Belatacept More Intensive (MI) Regimen	Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36	Month 12 (n = 184,175,184)	87 percentage of participants
Belatacept More Intensive (MI) Regimen	Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36	Month 24 (n = 177,170,179)	89.3 percentage of participants
Belatacept More Intensive (MI) Regimen	Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36	Month 36 (n = 151,145,143)	89.4 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36	Month 36 (n = 151,145,143)	87.6 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36	Month 12 (n = 184,175,184)	83.4 percentage of participants
Belatacept Less Intensive (LI) Regimen	Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36	Month 24 (n = 177,170,179)	84.7 percentage of participants
Cyclosporin A (CsA)	Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36	Month 24 (n = 177,170,179)	89.4 percentage of participants
Cyclosporin A (CsA)	Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36	Month 36 (n = 151,145,143)	90.9 percentage of participants
Cyclosporin A (CsA)	Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36	Month 12 (n = 184,175,184)	87.0 percentage of participants

Secondary

Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months

Participants were determined to have hypertension at a particular time point if standardized systolic blood pressure ≥ 130 mm Hg or standardized diastolic blood pressure ≥ 80 mm Hg or participant had received an anti-hypertensive medication(s) for hypertension. Here 'n' signifies those participants evaluable for this measure at specified time points for each arm, respectively.

Time frame: Months 12, 24 and 36

Population: All randomized and transplanted participants

Arm	Measure	Group	Value (MEAN)	Dispersion
Belatacept More Intensive (MI) Regimen	Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months	Diastolic BP (Month 12) (n= 184,175,184)	77.8 mmHg	Standard Deviation 13.83
Belatacept More Intensive (MI) Regimen	Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months	Systolic BP (Month 36) (n= 112,119,108)	134.9 mmHg	Standard Deviation 19.54
Belatacept More Intensive (MI) Regimen	Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months	Systolic BP (Month 12) (n= 184,175,184)	141.4 mmHg	Standard Deviation 21.29
Belatacept More Intensive (MI) Regimen	Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months	Diastolic BP (Month 24) (n= 120,129,120)	78.2 mmHg	Standard Deviation 13.28
Belatacept More Intensive (MI) Regimen	Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months	Systolic BP (Month 24) (n= 120,129,120)	138.82 mmHg	Standard Deviation 24.31
Belatacept More Intensive (MI) Regimen	Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months	Diastolic BP (Month 36) (n= 112,119,108)	75.4 mmHg	Standard Deviation 11.55
Belatacept Less Intensive (LI) Regimen	Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months	Diastolic BP (Month 36) (n= 112,119,108)	75.2 mmHg	Standard Deviation 10.85
Belatacept Less Intensive (LI) Regimen	Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months	Systolic BP (Month 24) (n= 120,129,120)	136.7 mmHg	Standard Deviation 20.96
Belatacept Less Intensive (LI) Regimen	Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months	Systolic BP (Month 36) (n= 112,119,108)	134.7 mmHg	Standard Deviation 21.59
Belatacept Less Intensive (LI) Regimen	Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months	Diastolic BP (Month 24) (n= 120,129,120)	77.0 mmHg	Standard Deviation 11.18
Belatacept Less Intensive (LI) Regimen	Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months	Diastolic BP (Month 12) (n= 184,175,184)	78.3 mmHg	Standard Deviation 10.62
Belatacept Less Intensive (LI) Regimen	Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months	Systolic BP (Month 12) (n= 184,175,184)	140.9 mmHg	Standard Deviation 21.09
Cyclosporin A (CsA)	Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months	Diastolic BP (Month 12) (n= 184,175,184)	81.8 mmHg	Standard Deviation 11.68
Cyclosporin A (CsA)	Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months	Systolic BP (Month 12) (n= 184,175,184)	149.5 mmHg	Standard Deviation 19.81
Cyclosporin A (CsA)	Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months	Diastolic BP (Month 36) (n= 112,119,108)	77.2 mmHg	Standard Deviation 11.79
Cyclosporin A (CsA)	Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months	Diastolic BP (Month 24) (n= 120,129,120)	81.7 mmHg	Standard Deviation 11.47
Cyclosporin A (CsA)	Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months	Systolic BP (Month 36) (n= 112,119,108)	140.7 mmHg	Standard Deviation 21.19
Cyclosporin A (CsA)	Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months	Systolic BP (Month 24) (n= 120,129,120)	146.8 mmHg	Standard Deviation 21.11

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Participants Who Survived With a Graft at 12 Months Post-Transplant

Percentage of Participants With a Measured Glomerular Filtration Rate (GFR) <60 mL/Min Per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/Min Per 1.73 m^2 From Month 3 to Month 12

Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months

Change in Calculated GFR at Months 12, 24, 36 and 84

Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36

Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36

Mean Framingham Risk Score From Baseline to Months 12, 24 and 36

Measured Glomerular Filtration Rate (GFR) by Month 12 and 24

Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84

Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84

Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months

Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months

Number of Participants With Laboratory Test Abnormalities up to 36 Months

Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months

Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84

Percentage of Participants Who Survived With a Graft at 24 and 36 Months Post-Transplant

Percentage of Participants With Chronic Allograft Nephropathy (CAN) at Month 12

Percentage of Participants With Graft Loss or Death to Month 84

Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.

Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36

Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months