Table 2.
Treatment differences in primary and secondary efficacy endpoints at Week 24
| Parameters | Arm 1 | Arm 2 | Arm 3 | p‐value | ||
|---|---|---|---|---|---|---|
| Arm 1 vs Arm 2 | Arm 1 vs Arm 3 | Arm 2 vs Arm 3 | ||||
| Primary efficacy endpoint Renal function*, LS mean in mL/min/1.73m2 | ||||||
| eGFR (MDRD4) | 67.4 | 76.4 | 73.3 | 0.001 | 0.047 | 0.230 |
| Secondary efficacy endpoint Renal function*, LS mean (n) in mL/min/1.73m2 | ||||||
| CrCl (Cockcroft–Gault) | 67.2 (278) | 76.7 (283) | 72.9 (269) | < 0.001 | 0.071 | 0.152 |
| eGFR (CKD‐EPI) | 65.7 (278) | 73.5 (283) | 71.0 (269) | 0.002 | 0.046 | 0.282 |
| eGFR (cystatin C) | 60.5 (209) | 64.8 (204) | 64.9 (193) | 0.268 | 0.256 | 0.972 |
| GFR (iohexol clearance) | 56.5 (173) | 56.9 (183) | 52.6 (172) | 0.945 | 0.445 | 0.401 |
| Composite efficacy failure‐free survival†, n (%) | 210 (72.0) | 227 (77.6) | 206 (73.9) | 0.065 | 0.726 | 0.161 |
| Graft survival†, n (%) | 251 (86.5) | 256 (87.7) | 246 (88.6) | 0.642 | 0.479 | 0.793 |
| Patient survival†, n (%) | 259 (89.3) | 260 (89.1) | 251 (90.4) | 0.948 | 0.668 | 0.617 |
| Acute rejection†, n (%) | ||||||
| Patients with AR | 52 (18.0) | 36 (12.4) | 51 (18.4) | 0.025 | 0.890 | 0.019 |
| Rejection episode | ||||||
| 0 | 235 (81.3) | 252 (86.6) | 223 (80.5) | – | – | – |
| 1 | 46 (15.9) | 34 (11.7) | 47 (17.0) | – | – | – |
| 2 | 8 (2.8) | 4 (1.4) | 7 (2.5) | – | – | – |
| 3 | 0 (0.0) | 1 (0.3) | 0 (0.0) | – | – | – |
| BCAR†, n (%) | ||||||
| Patients with BCAR | 46 (17.9%) | 30 (12.1%) | 42 (16.8%) | 0.016 | 0.782 | 0.039 |
*Analyses using FAS: n = 283, n = 287, n = 274 for Arms 1–3, respectively. †Analyses using mITT: n = 289, n = 291, n = 277 for Arms 1–3.
Composite efficacy failure, graft and patient survival, acute rejection and BCAR were analyzed by Kaplan–Meier analysis. AR, acute rejection; BCAR, biopsy‐confirmed acute rejection; CKD‐EPI, Chronic Kidney Disease Epidemiology Collaboration; CrCl, creatinine clearance; eGFR, estimated glomerular filtration rate; FAS, full‐analysis set; GFR, glomerular filtration rate; LS, least‐square; MDRD4, Modification of Diet in Renal Disease‐4; mITT, modified intent to treat.