Trial Outcomes & Findings for Bela 8 Week Dosing (NCT NCT02560558)
NCT ID: NCT02560558
Last Updated: 2020-09-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
166 participants
Primary outcome timeframe
12 months from baseline
Results posted on
2020-09-18
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
82
|
|
Overall Study
COMPLETED
|
77
|
76
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
Reasons for withdrawal
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Death
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
|
Overall Study
Protocol Violation
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
Bela 8 Week Dosing
Baseline characteristics by cohort
| Measure |
Belatacept 8-weekly
n=81 Participants
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.
|
Belatacept 4-weekly
n=82 Participants
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
n=163 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 13 • n=99 Participants
|
52 years
STANDARD_DEVIATION 12 • n=107 Participants
|
51 years
STANDARD_DEVIATION 12.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
117 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
36 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non African American
|
45 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=99 Participants
|
82 participants
n=107 Participants
|
163 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 months from baselineThe 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.
Outcome measures
| Measure |
Belatacept 8-weekly
n=77 Participants
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.
|
Belatacept 4-weekly
n=76 Participants
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.
|
|---|---|---|
|
Mean Estimated Glomerular Filtration Rate (eGFR) at 12 Months From Baseline
|
72.13 ml/min/1.73m^2
Interval 70.14 to 74.12
|
72.65 ml/min/1.73m^2
Interval 70.64 to 74.65
|
SECONDARY outcome
Timeframe: 6 months post baseline, 12 months post baselineThe number of occurrences of transplant rejection at 6 months and 12 months from baseline will be recorded.
Outcome measures
| Measure |
Belatacept 8-weekly
n=77 Participants
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.
|
Belatacept 4-weekly
n=76 Participants
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.
|
|---|---|---|
|
Number of Participants With Transplant Rejection at 6 Months and 12 Months Post Baseline
6 months post baseline
|
3 Participants
|
1 Participants
|
|
Number of Participants With Transplant Rejection at 6 Months and 12 Months Post Baseline
12 months post baseline
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 months post baseline, 12 months post baselineThe 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.
Outcome measures
| Measure |
Belatacept 8-weekly
n=77 Participants
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.
|
Belatacept 4-weekly
n=76 Participants
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.
|
|---|---|---|
|
Number of Subjects With Grade IIA and Lower Rejections at 6 Months and 12 Months Post Baseline
6 months post baseline
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Grade IIA and Lower Rejections at 6 Months and 12 Months Post Baseline
12 months post baseline
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 months post baseline, 12 months post baselineThe 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.
Outcome measures
| Measure |
Belatacept 8-weekly
n=77 Participants
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.
|
Belatacept 4-weekly
n=76 Participants
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.
|
|---|---|---|
|
Number of Subjects With Grade IIB and Higher Rejections at 6 Months and 12 Months Post Baseline
6 months post baseline
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Grade IIB and Higher Rejections at 6 Months and 12 Months Post Baseline
12 months post baseline
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months post baseline, 12 months post baselineThe total number of subject deaths at 12 months from baseline will be recorded.
Outcome measures
| Measure |
Belatacept 8-weekly
n=77 Participants
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.
|
Belatacept 4-weekly
n=76 Participants
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.
|
|---|---|---|
|
Number of Deaths at 6 Months and 12 Months Post Baseline
6 months post baseline
|
0 Participants
|
1 Participants
|
|
Number of Deaths at 6 Months and 12 Months Post Baseline
12 months post baseline
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 months post baseline, 12 months from baselineThe total number of subjects who experienced death censored graft loss at 6 months and 12 months from baseline will be recorded.
Outcome measures
| Measure |
Belatacept 8-weekly
n=77 Participants
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.
|
Belatacept 4-weekly
n=76 Participants
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.
|
|---|---|---|
|
Number of Subjects That Experienced Graft Loss at 6 Moths and 12 Months Post Baseline
6 months post baseline
|
0 Participants
|
0 Participants
|
|
Number of Subjects That Experienced Graft Loss at 6 Moths and 12 Months Post Baseline
12 months post baseline
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 moths post baseline, 12 months post baselineThe number of subjects who have circulating human leukocyte antigen donor specific antibodies (HLA DSA) at 12 months from baseline will be recorded.
Outcome measures
| Measure |
Belatacept 8-weekly
n=77 Participants
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.
|
Belatacept 4-weekly
n=76 Participants
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.
|
|---|---|---|
|
Number of Subjects With Human Leukocyte Antigen Donor Specific Antibodies (HLA DSA) at 6 Months and 12 Months Post Baseline
6 months post baseline
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Human Leukocyte Antigen Donor Specific Antibodies (HLA DSA) at 6 Months and 12 Months Post Baseline
12 months post baseline
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 12 months from baselinePopulation: Resources/tools not available for recording/tracking the data required to reliably report the outcome.
The number of clinic visits by the subjects at the end of 12 months from baseline will be recorded.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 12 months from baselinePopulation: Resources/tools not available for recording/tracking the data required to reliably report the outcome.
The number of subjects who had hospitalizations at the end of 12 months from baseline will be recorded
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months post baselineThe number of subjects needing transplant biopsies at 12 months from baseline will be recorded.
Outcome measures
| Measure |
Belatacept 8-weekly
n=77 Participants
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.
|
Belatacept 4-weekly
n=76 Participants
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.
|
|---|---|---|
|
Number of Subjects Needing Transplant Biopsies at 12 Months Post Baseline
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At 12 months from baselinePopulation: Resources/tools not available for recording/tracking the data required to reliably report the outcome.
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.
Outcome measures
Outcome data not reported
Adverse Events
Belatacept 8-weekly
Serious events: 9 serious events
Other events: 23 other events
Deaths: 0 deaths
Belatacept 4-weekly
Serious events: 10 serious events
Other events: 27 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Belatacept 8-weekly
n=81 participants at risk
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.
|
Belatacept 4-weekly
n=82 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Infectious Severe Adverse Events
|
6.2%
5/81 • Number of events 6 • Up to 12 months post baseline
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)
|
7.3%
6/82 • Number of events 8 • Up to 12 months post baseline
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)
|
|
General disorders
Non Infectious severe Adverse Events
|
4.9%
4/81 • Number of events 4 • Up to 12 months post baseline
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)
|
4.9%
4/82 • Number of events 6 • Up to 12 months post baseline
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)
|
Other adverse events
| Measure |
Belatacept 8-weekly
n=81 participants at risk
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.
|
Belatacept 4-weekly
n=82 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Infectious Adverse Events
|
23.5%
19/81 • Number of events 27 • Up to 12 months post baseline
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)
|
29.3%
24/82 • Number of events 30 • Up to 12 months post baseline
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)
|
|
Skin and subcutaneous tissue disorders
Non melanoma skin cancer
|
4.9%
4/81 • Number of events 5 • Up to 12 months post baseline
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)
|
1.2%
1/82 • Number of events 1 • Up to 12 months post baseline
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)
|
|
General disorders
Other
|
4.9%
4/81 • Number of events 5 • Up to 12 months post baseline
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)
|
3.7%
3/82 • Number of events 3 • Up to 12 months post baseline
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)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place