Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression (BENEFIT)
Summary
The purpose of this study is to learn if Belatacept can provide protection from organ rejection following kidney transplantation while avoiding some of the toxic effects of standard immunosuppressive medications such as kidney damage. Effects on kidney function and patient survival as well as drug safety will also be studied.
Timeline
- Start
- 2005-03
- Primary completion
- 2008-06
- Completion
- 2015-04
Outcome
Mixed primary results
registry analysis (non-inferiority or equivalence test); Cyclosporine vs Belatacept LI; Difference in Percent 3.7 (97.3% CI -1.1 to 9.0) NCT00256750 ↗
registry analysis (superiority or other test); Cyclosporine vs Belatacept LI; p <.0001; Difference in Percent -23.7 (97.3% CI -33.3 to -13.7); Chi-squared, Corrected NCT00256750 ↗
registry analysis (non-inferiority or equivalence test); Cyclosporine vs Belatacept LI; Difference in Percent 10.0 (97.3% CI 3.3 to 17.1) NCT00256750 ↗
registry analysis (non-inferiority or equivalence test); Cyclosporine vs Belatacept MI; Difference in Percent 14.7 (97.3% CI 7.5 to 22.2) NCT00256750 ↗
Publications
- Vincenti F, Rostaing L, Grinyo J, Rice K, Steinberg S, Gaite L, Moal MC, Mondragon-Ramirez GA, Kothari J, Polinsky MS, Meier-Kriesche HU, Munier S, Larsen CP. Belatacept and Long-Term Outcomes in Kidney Transplantation. N Engl J Med. 2016 Jan 28;374(4):333-43. doi: 10.1056/NEJMoa1506027.
- Dobbels F, Wong S, Min Y, Sam J, Kalsekar A. Beneficial effect of belatacept on health-related quality of life and perceived side effects: results from the BENEFIT and BENEFIT-EXT trials. Transplantation. 2014 Nov 15;98(9):960-8. doi: 10.1097/TP.0000000000000159.
- Vincenti F, Larsen CP, Alberu J, Bresnahan B, Garcia VD, Kothari J, Lang P, Urrea EM, Massari P, Mondragon-Ramirez G, Reyes-Acevedo R, Rice K, Rostaing L, Steinberg S, Xing J, Agarwal M, Harler MB, Charpentier B. Three-year outcomes from BENEFIT, a randomized, active-controlled, parallel-group study in adult kidney transplant recipients. Am J Transplant. 2012 Jan;12(1):210-7. doi: 10.1111/j.1600-6143.2011.03785.x. Epub 2011 Oct 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Belatacept | Protein / enzyme biologic | 5 mg/kg | Intravenous |
| Comparator | Cyclosporine | Peptide | — | Oral |