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Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial - Extended Criteria Donors (BENEFIT-EXT)
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.
Details
| Lead sponsor | Bristol-Myers Squibb |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 595 |
| Start date | 2005-02 |
| Completion | 2014-09 |
Conditions
- Renal Transplantation
Interventions
- Cyclosporin A
- Belatacept Less Intensive Regimen (LI)
- Belatacept More Intensive Regimen (MI)
Primary outcomes
- 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.
Countries
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, France, Germany, Hungary, Italy, Norway, Poland, South Africa, Spain, Sweden, United Kingdom