Efficacy
| Group 1 | Group 2 | ||
|---|---|---|---|
| FAS | 60 | 55 | |
| NODAT | 14 (23.3) | 3 (5.5) | 0.015 |
| BPAR | 2 (3.3) | 2 (3.6) | 0.929 |
| Treatment failure | 20 (33.3) | 17 (30.9) | 0.781 |
| Graft failure | 2 (3.3) | 1 (1.8) | 0.611 |
| Death | 1 (1.7) | 0 (0) | 0.336 |
| CRF | 0 (0) | 2 (3.6) | 0.227 |
| CKD | 25 (41.7) | 17 (30.9) | 0.234 |
| Infection | 17 (28.3) | 20 (36.4) | 0.426 |
| HCC (n = 34) | 2/20 (10.0) | 1/14 (7.1) | 0.773 |
| PPS | 37 | 30 | |
| NODAT | 12 (32.4) | 3 (10.0) | 0.029 |
| BPAR | 0 (0) | 0 (0) | |
| Treatment failure | 6 (16.2) | 7 (23.3) | 0.464 |
| Graft failure | 0 (0) | 0 (0) | |
| Death | 0 (0) | 0 (0) | |
| CRF | 0 (0) | 1 (3.3) | 0.478 |
| CKD | 17 (46.0) | 11 (36.7) | 0.444 |
Values are presented as number only or number (%).
Group 1, steroid withdrawal at 2 weeks after transplantation; Group 2, steroid withdrawal at 3 months after transplantation.
FAS, full-analysis set; NODAT, new-onset diabetes after transplantation; BPAR, biopsy-proven acute rejection; CRF, chronic renal failure; CKD, chronic kidney disease; HCC, hepatocellular carcinoma; PPS, per-protocol set.