Phase 4
Completed N=166
Bela 8 Week Dosing
Source: ClinicalTrials.gov NCT02560558 ↗Enrolled (actual)
166
Serious AEs
11.7%
Results posted
Sep 2020
Primary outcomePrimary: Mean Estimated Glomerular Filtration Rate (eGFR) at 12 Months From Baseline — 72.13; 72.65 ml/min/1.73m^2
◆ Published Evidence
Emerging
19citations · ~4 / year
Every 2-month belatacept maintenance therapy in kidney transplant recipients greater than 1-year posttransplant: A randomized, noninferiority trial.
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.
Linked Publications
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Every 2-month belatacept maintenance therapy in kidney transplant recipients greater than 1-year posttransplant: A randomized, noninferiority trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Estimated Glomerular Filtration Rate (eGFR) at 12 Months From Baseline |
72.13; 72.65 | — |
| SECONDARY Number of Participants With Transplant Rejection at 6 Months and 12 Months Post Baseline |
3; 1; 4; 2 | — |
| SECONDARY Number of Subjects With Grade IIA and Lower Rejections at 6 Months and 12 Months Post Baseline |
3; 1; 4; 2 | — |
| SECONDARY Number of Subjects With Grade IIB and Higher Rejections at 6 Months and 12 Months Post Baseline |
0; 0; 0; 0 | — |
| SECONDARY Number of Deaths at 6 Months and 12 Months Post Baseline |
0; 1; 0; 2 | — |
| SECONDARY Number of Subjects That Experienced Graft Loss at 6 Moths and 12 Months Post Baseline |
0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Human Leukocyte Antigen Donor Specific Antibodies (HLA DSA) at 6 Months and 12 Months Post Baseline |
2; 0; 3; 0 | — |
| SECONDARY Number of Clinic Visits |
— | — |
| SECONDARY Number of Subjects Needing Hospitalizations |
— | — |
| SECONDARY Number of Subjects Needing Transplant Biopsies at 12 Months Post Baseline |
5; 2 | — |
| SECONDARY Cost Analysis |
— | — |
Eligibility Criteria
Inclusion Criteria
- Adult (age ≥18 years currently),
- First-time renal transplant recipients of either living donor or deceased donor,
- who were initiated on belatacept at the time of transplant and
- are at least one year post-transplant and off CNI therapy for at least 6 months.
- Patients at low immunologic risk, defined as
- patients with a first transplant who have a PRA 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.
Data sourced from ClinicalTrials.gov (NCT02560558) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.