Table 1.
Clinical trials of de novo belatacept in renal transplantation.
| Trial | Treatment groups | Acute rejection | Graft loss | GFR at end of study (ml/min/1.73 m2) | Notes |
|---|---|---|---|---|---|
| Phase III, randomized, partially blinded, multicenter (BENEFIT) | MI Belatacept | 49/219 (22%) | 4/219 (2%) | 65a | Basiliximab induction with MMF + steroids as maintenance |
| LI Belatacept | 39/226 (17%) | 5/226 (2%) | 63a | ||
| 1-year outcomes (9) | CsA | 16/221 (7%) | 8/221 (4%) | 50 | |
| Phase III, randomized, partially blinded, multicenter (BENEFIT) | MI Belatacept | 54/219 (24%) | 25/219 (12.7%) | 70b | Basiliximab induction with MMF + steroids as maintenance |
| LI Belatacept | 41/226 (18%) | 26/226 (12.8%) | 72b | ||
| 7-year outcomes (16) | CsA | 24/221 (11%) | 40/221 (21.7%) | 45 | |
| Phase III, randomized, partially blinded, multicenter (BENEFIT-EXT) | MI Belatacept | 33/184 (18%) | 17/184 (9%) | 52a | Basiliximab induction with MMF + steroids as maintenance |
| LI Belatacept | 31/175 (18%) | 16/175 (9%) | 49c | ||
| 1-year outcomes (25) | CsA | 26/184 (14%) | 20/184 (11%) | 45 | |
| Phase III, randomized, partially blinded, multicenter (BENEFIT-EXT) | MI Belatacept | 39/184 (21.1%) | 21/184 (12.4%) | 53.9b | Basiliximab induction with MMF + steroids as maintenance |
| LI Belatacept | 34/175 (19.5%) | 23/175 (13.6%) | 54.2b | ||
| 7-year outcomes (26) | CsA | 32/184 (17.3%) | 29/184 (19.3%) | 35.3 | |
ap < 0.01 vs standard CsA.
bp < 0.001 vs standard CsA.
cp = 0.1 vs standard CsA.
MI Belatacept, more intensive belatacept; LI Belatacept, less intensive belatacept; CsA, cyclosporine A; CNI, calcineurin inhibitor; MMF, mycophenolate mofetil; GFR, glomerular filtration rate; BENEFIT, Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial; BENEFIT-EXT, Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial—EXTended criteria donors.