Table 2.
Clinical trials of belatacept conversion in renal transplantation.
| Trial | Treatment groups | Acute rejection | Graft loss | GFR change (ml/min/1.73 m2) per year | Notes |
|---|---|---|---|---|---|
| Phase II, randomized | Belatacept | 6/84 (7%) | 0/84 (0%) | +7a | 1-year results, patients converted after 6 months with stable renal function |
| Switching CNI to belatacept (30) | CsA/Tac | 0/89 (0%) | 1/89 (1.1%) | +2 | |
| Phase II, randomized | Belatacept | 6/84 (7%) | 1/84 (1.2%) | +9 | 2-year results, patients converted after 6 months with stable renal function |
| Switching CNI to belatacept 2-year outcomes (31) |
CsA/Tac | 3/89 (3%) | 2/89 (2.2%) | +0.3 | |
| Phase II, randomized | Belatacept | 7/84 (8.4%) | 2/84 (2.4%) | +1.9b | 3-year results, patients converted after 6 months with stable renal function 3 year outcomes (32) |
| Switching CNI to belatacept | CsA/Tac | 3/89 (3.6%) | 2/89 (2.2%) | +0.07 | |
| Retrospective review | |||||
| Early switch from CNI to belatacept in extended criteria donor kidney donor transplantation (33) | CNI converted to Belatacept | 1/25 (4%) | 11/25 (44%) | +17c | Patients converted for prolonged delayed graft function and/or poor allograft function |
ap = 0.0058 for difference between treatment groups in change from baseline.
bp = 0.01 for difference between treatment groups in change from baseline.
cp = 0.001.
CsA, cyclosporine A; CNI, calcineurin inhibitor; MMF, mycophenolate mofetil; GFR, glomerular filtration rate; Tac, tacrolimus.