Bela 8 Week Dosing

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02560558
• Collaborator: (none)
• Enrollment: 166
• Locations: 2
• Arms: 2
• Duration (Months): 47.9
• Patients Per Site: 83
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The purpose of this study is to transition patients who have been stable on Belatacept for one year after kidney transplant from standard 4-week to an investigational 8-week belatacept dosing schedule. The investigators hypothesize that renal function and acute rejection rates will be non-inferior with 8-week belatacept dosing.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation	Drug: Belatacept	Phase 4

Detailed Description

The current dosing protocol for patients who have undergone a kidney transplant requires that Belatacept be given as an infusion every 4 weeks. The investigator wants to assess if the patients who have been stable for one year after transplant can be safely transitioned to an 8-week Belatacept infusion schedule. Renal function and any episodes of acute rejection will be closely monitored.

Study Design

• Study Type: Interventional
• Actual Enrollment: 166 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Belatacept Immunosuppression Therapy in Post-Transplant Kidney Recipients: Comparison of 4-Week and 8-Week Dosing Intervals
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Aug 29, 2019
• Actual Study Completion Date: Aug 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Belatacept 8-weekly Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks.	Drug: Belatacept; Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.; Other Names: Nulojix
Active Comparator: Belatacept 4-weekly Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks.	Drug: Belatacept; Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.; Other Names: Nulojix

Outcome Measures

Primary Outcome Measures

1. Mean Estimated Glomerular Filtration Rate (eGFR) at 12 Months From Baseline [12 months from baseline]

   The mean estimated Glomerular Filtration Rate (eGFR) will be calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation using serum creatinine measurements and the patient's age, gender, and race. An eGFR below 60 ml/min/1.73 m^2 indicates lower renal function.

Secondary Outcome Measures

1. Number of Participants With Transplant Rejection at 6 Months and 12 Months Post Baseline [6 months post baseline, 12 months post baseline]

   The number of occurrences of transplant rejection at 6 months and 12 months from baseline will be recorded.

2. Number of Subjects With Grade IIA and Lower Rejections at 6 Months and 12 Months Post Baseline [6 months post baseline, 12 months post baseline]

   The number of subjects with Grade IIA and lower severity of rejection on the Banff 97 diagnostic categories will be recorded. The severity of acute rejections will be graded based on histopathological findings; Grade IA= significant interstitial infiltration and moderate tubulitis; Grade IB= significant interstitial infiltration and severe tubulitis; Grade IIA= mild to moderate intimal arteritis; Grade IIB= severe intimal arteritis and Grade III= transmural arteritis and/or fibrinoid change and necrosis of cells.

3. Number of Subjects With Grade IIB and Higher Rejections at 6 Months and 12 Months Post Baseline [6 months post baseline, 12 months post baseline]

   The number of subjects with Grade IIB and higher severity of rejection on the Banff 97 diagnostic categories will be recorded. The severity of acute rejections will be graded based on histopathological findings; Grade IA= significant interstitial infiltration and moderate tubulitis; Grade IB= significant interstitial infiltration and severe tubulitis; Grade IIA= mild to moderate intimal arteritis; Grade IIB= severe intimal arteritis and Grade III= transmural arteritis and/or fibrinoid change and necrosis of cells.

4. Number of Deaths at 6 Months and 12 Months Post Baseline [6 months post baseline, 12 months post baseline]

   The total number of subject deaths at 12 months from baseline will be recorded.

5. Number of Subjects That Experienced Graft Loss at 6 Moths and 12 Months Post Baseline [6 months post baseline, 12 months from baseline]

   The total number of subjects who experienced death censored graft loss at 6 months and 12 months from baseline will be recorded.

6. Number of Subjects With Human Leukocyte Antigen Donor Specific Antibodies (HLA DSA) at 6 Months and 12 Months Post Baseline [6 moths post baseline, 12 months post baseline]

   The number of subjects who have circulating human leukocyte antigen donor specific antibodies (HLA DSA) at 12 months from baseline will be recorded.

7. Number of Clinic Visits [At 12 months from baseline]

   The number of clinic visits by the subjects at the end of 12 months from baseline will be recorded.

8. Number of Subjects Needing Hospitalizations [At 12 months from baseline]

   The number of subjects who had hospitalizations at the end of 12 months from baseline will be recorded

9. Number of Subjects Needing Transplant Biopsies at 12 Months Post Baseline [12 months post baseline]

   The number of subjects needing transplant biopsies at 12 months from baseline will be recorded.

10. Cost Analysis [At 12 months from baseline]

    The mean total cost of infusions received by each subject and those associated with round trip travel to the Emory Transplant Center (ETC) will be estimated using the distance between the residential addresses of subjects and the ETC.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult (age ≥18 years currently),

• First-time renal transplant recipients of either living donor or deceased donor,

1. who were initiated on belatacept at the time of transplant and

2. are at least one year post-transplant and off CNI therapy for at least 6 months.

• Patients at low immunologic risk, defined as

1. patients with a first transplant who have a PRA < 50 against class I and class II antigens,

2. no DSA (donor-specific antibodies),

3. who have not had more than one episode of rejection, and

4. no episodes of rejection within the last 6 months prior to enrollment, and

5. no rejection with a grade of IIB or above.

Exclusion Criteria:

• Not first renal transplant, or multi-organ transplant recipient

• History of greater than one episode of biopsy-proven acute rejection, or of rejection of Banff 97 grade IIB or greater, or rejection within the last 6 months.

• Pregnancy (women of childbearing potential must use adequate contraception during study)

• Unwilling to receive all belatacept infusions at the Emory Transplant Center

• Calculated Glomerular Filtration Rate (GFR) less than 35.

• Serum creatinine at enrollment over 30% higher than 3 months (±4 weeks) prior to randomization

• HbA1C greater than 8 at enrollment

• Recent history of significant proteinuria (protein/Cr ratio >1)

• Non-standard belatacept dosing (e.g. dose other than 5 mg belatacept/kg body weight)

• Cellcept dose less than 500 mg po bid.

• Prednisone dose greater than 5mg po qd within 3 months of randomization

• Patients not currently taking prednisone

• Active infection, or antibiotic or antiviral drug therapy within 1 month of randomization

• Evidence of Cytomegalovirus (CMV) viremia or clinical CMV infection within last 3 months.

• Polyomavirus BK PCR (polymerase chain reaction) load greater then 4.3 (copy number greater than 20,0000) within 3 months of randomization

• Known hepatitis B surface antigen-positive or PCR-positive for hepatitis B (testing not required)

• Known HIV (human immunodeficiency virus infection) (testing not required)

• Presence of donor specific antibody by Luminex single antigen assessment, or panel reactivity (PRA) above 50%.

• History of substance abuse or psychiatric disorder not compatible with study adherence and follow up.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory Clinic	Atlanta	Georgia	United States	30322
2	Emory University Hospital	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

• Emory University

Investigators

• Principal Investigator: Idelberto Badell, MD, Emory University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 10, 2018

More Information

Publications

None provided.

• Responsible Party: Idelberto Badell, Assistant Professor, Emory University
• ClinicalTrials.gov Identifier: NCT02560558
• Other Study ID Numbers: IRB00082511
• First Posted: Sep 25, 2015
• Last Update Posted: Sep 18, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Idelberto Badell, Assistant Professor, Emory University: Immunosuppression; Transplantation Immunology
• Additional relevant MeSH terms: Abatacept

Study Results

Participant Flow

Arm/Group Title	Belatacept 8-weekly	Belatacept 4-weekly
Arm/Group Description	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.
Period Title: Overall Study
STARTED	84	82
COMPLETED	77	76
NOT COMPLETED	7	6

Baseline Characteristics

Arm/Group Title	Belatacept 8-weekly	Belatacept 4-weekly	Total
Arm/Group Description	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.	Total of all reporting groups
Overall Participants	81	82	163
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50 (13)	52 (12)	51 (12.7)
Sex: Female, Male (Count of Participants)
Female	27 33.3%	19 23.2%	46 28.2%
Male	54 66.7%	63 76.8%	117 71.8%
Race/Ethnicity, Customized (Count of Participants)
African American	36 44.4%	32 39%	68 41.7%
Non African American	45 55.6%	50 61%	95 58.3%
Region of Enrollment (participants) [Number]
United States	81 100%	82 100%	163 100%

Outcome Measures

1. Primary Outcome

Title	Mean Estimated Glomerular Filtration Rate (eGFR) at 12 Months From Baseline
Description	The mean estimated Glomerular Filtration Rate (eGFR) will be calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation using serum creatinine measurements and the patient's age, gender, and race. An eGFR below 60 ml/min/1.73 m^2 indicates lower renal function.
Time Frame	12 months from baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Belatacept 8-weekly	Belatacept 4-weekly
Arm/Group Description	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.
Measure Participants	77	76
Mean (95% Confidence Interval) [ml/min/1.73m^2]	72.13	72.65

2. Secondary Outcome

Title	Number of Participants With Transplant Rejection at 6 Months and 12 Months Post Baseline
Description	The number of occurrences of transplant rejection at 6 months and 12 months from baseline will be recorded.
Time Frame	6 months post baseline, 12 months post baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Belatacept 8-weekly	Belatacept 4-weekly
Arm/Group Description	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.
Measure Participants	77	76
6 months post baseline	3 3.7%	1 1.2%
12 months post baseline	4 4.9%	2 2.4%

3. Secondary Outcome

Title	Number of Subjects With Grade IIA and Lower Rejections at 6 Months and 12 Months Post Baseline
Description	The number of subjects with Grade IIA and lower severity of rejection on the Banff 97 diagnostic categories will be recorded. The severity of acute rejections will be graded based on histopathological findings; Grade IA= significant interstitial infiltration and moderate tubulitis; Grade IB= significant interstitial infiltration and severe tubulitis; Grade IIA= mild to moderate intimal arteritis; Grade IIB= severe intimal arteritis and Grade III= transmural arteritis and/or fibrinoid change and necrosis of cells.
Time Frame	6 months post baseline, 12 months post baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Belatacept 8-weekly	Belatacept 4-weekly
Arm/Group Description	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.
Measure Participants	77	76
6 months post baseline	3 3.7%	1 1.2%
12 months post baseline	4 4.9%	2 2.4%

4. Secondary Outcome

Title	Number of Subjects With Grade IIB and Higher Rejections at 6 Months and 12 Months Post Baseline
Description	The number of subjects with Grade IIB and higher severity of rejection on the Banff 97 diagnostic categories will be recorded. The severity of acute rejections will be graded based on histopathological findings; Grade IA= significant interstitial infiltration and moderate tubulitis; Grade IB= significant interstitial infiltration and severe tubulitis; Grade IIA= mild to moderate intimal arteritis; Grade IIB= severe intimal arteritis and Grade III= transmural arteritis and/or fibrinoid change and necrosis of cells.
Time Frame	6 months post baseline, 12 months post baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Belatacept 8-weekly	Belatacept 4-weekly
Arm/Group Description	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.
Measure Participants	77	76
6 months post baseline	0 0%	0 0%
12 months post baseline	0 0%	0 0%

5. Secondary Outcome

Title	Number of Deaths at 6 Months and 12 Months Post Baseline
Description	The total number of subject deaths at 12 months from baseline will be recorded.
Time Frame	6 months post baseline, 12 months post baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Belatacept 8-weekly	Belatacept 4-weekly
Arm/Group Description	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.
Measure Participants	77	76
6 months post baseline	0 0%	1 1.2%
12 months post baseline	0 0%	2 2.4%

6. Secondary Outcome

Title	Number of Subjects That Experienced Graft Loss at 6 Moths and 12 Months Post Baseline
Description	The total number of subjects who experienced death censored graft loss at 6 months and 12 months from baseline will be recorded.
Time Frame	6 months post baseline, 12 months from baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Belatacept 8-weekly	Belatacept 4-weekly
Arm/Group Description	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.
Measure Participants	77	76
6 months post baseline	0 0%	0 0%
12 months post baseline	0 0%	0 0%

7. Secondary Outcome

Title	Number of Subjects With Human Leukocyte Antigen Donor Specific Antibodies (HLA DSA) at 6 Months and 12 Months Post Baseline
Description	The number of subjects who have circulating human leukocyte antigen donor specific antibodies (HLA DSA) at 12 months from baseline will be recorded.
Time Frame	6 moths post baseline, 12 months post baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Belatacept 8-weekly	Belatacept 4-weekly
Arm/Group Description	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.
Measure Participants	77	76
6 months post baseline	2 2.5%	0 0%
12 months post baseline	3 3.7%	0 0%

8. Secondary Outcome

Title	Number of Clinic Visits
Description	The number of clinic visits by the subjects at the end of 12 months from baseline will be recorded.
Time Frame	At 12 months from baseline

Outcome Measure Data

Analysis Population Description

Resources/tools not available for recording/tracking the data required to reliably report the outcome.

Arm/Group Title	Belatacept 8-weekly	Belatacept 4-weekly
Arm/Group Description	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.
Measure Participants	0	0

9. Secondary Outcome

Title	Number of Subjects Needing Hospitalizations
Description	The number of subjects who had hospitalizations at the end of 12 months from baseline will be recorded
Time Frame	At 12 months from baseline

Outcome Measure Data

Analysis Population Description

Resources/tools not available for recording/tracking the data required to reliably report the outcome.

Arm/Group Title	Belatacept 8-weekly	Belatacept 4-weekly
Arm/Group Description	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.
Measure Participants	0	0

10. Secondary Outcome

Title	Number of Subjects Needing Transplant Biopsies at 12 Months Post Baseline
Description	The number of subjects needing transplant biopsies at 12 months from baseline will be recorded.
Time Frame	12 months post baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Belatacept 8-weekly	Belatacept 4-weekly
Arm/Group Description	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.
Measure Participants	77	76
Count of Participants [Participants]	5 6.2%	2 2.4%

11. Secondary Outcome

Title	Cost Analysis
Description	The mean total cost of infusions received by each subject and those associated with round trip travel to the Emory Transplant Center (ETC) will be estimated using the distance between the residential addresses of subjects and the ETC.
Time Frame	At 12 months from baseline

Outcome Measure Data

Analysis Population Description

Resources/tools not available for recording/tracking the data required to reliably report the outcome.

Arm/Group Title	Belatacept 8-weekly	Belatacept 4-weekly
Arm/Group Description	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.
Measure Participants	0	0

Adverse Events

Time Frame	Up to 12 months post baseline
Adverse Event Reporting Description	Adverse events were captured through active surveillance via open ended questions by the research coordinator at each study visit in accordance with the Common Terminology Criteria for Adverse Events (CTCAE)
Arm/Group Title	Belatacept 8-weekly		Belatacept 4-weekly
Arm/Group Description	Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 8 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.		Subjects who are stable on belatacept therapy at least one year after a renal transplant will receive belatacept infusion intravenously (IV) at 5 mg/kg every 4 weeks. Belatacept: Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.
All Cause Mortality
	Belatacept 8-weekly		Belatacept 4-weekly
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/77 (0%)		2/76 (2.6%)
Serious Adverse Events
	Belatacept 8-weekly		Belatacept 4-weekly
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/81 (11.1%)		10/82 (12.2%)
General disorders
Non Infectious severe Adverse Events	4/81 (4.9%)	4	4/82 (4.9%)	6
Infections and infestations
Infectious Severe Adverse Events	5/81 (6.2%)	6	6/82 (7.3%)	8
Other (Not Including Serious) Adverse Events
	Belatacept 8-weekly		Belatacept 4-weekly
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	23/81 (28.4%)		27/82 (32.9%)
General disorders
Other	4/81 (4.9%)	5	3/82 (3.7%)	3
Infections and infestations
Infectious Adverse Events	19/81 (23.5%)	27	24/82 (29.3%)	30
Skin and subcutaneous tissue disorders
Non melanoma skin cancer	4/81 (4.9%)	5	1/82 (1.2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.