Table 2.
Secondary End-Points
| Secondary end-points | |||
|---|---|---|---|
| Steroid-free treatment group | Steroid-based treatment group | P value | |
| Number of patients | 60 | 70 | |
| Patient survival by 3 years | 60/60 (100%) | 70/70 (100%) | NA |
| Graft survival by 3 years | 57/60 (95.0%) | 63/70 (90.0%) | 0.30 |
| Delayed graft function | 4/60 (6.7%) | 1/70 (1.4%) | 0.18 |
| Graft function (Schwartz eGFR, mL/min/1.73m2) | |||
| At 1 year (mean ± SD; median) | 100 ± 28.8; 102 (N=56) | 103 ± 33.9; 101 (N=63) | 0.90 |
| At 3 years (mean ± SD; median) | 86.3 ± 30.5; 89 (N=49) | 83.9 ± 28.5; 85 (N=48) | 0.72 |
| Acute T-cell mediated rejection in indication biopsies (graft dysfunction) | |||
| Cumulative prevalence at 1 year | 8/60 (13.3%) | 8/70 (11.4%) | 0.74 |
| Cumulative prevalence at 3 years | 10/60 (16.7%) | 12/70 (17.1%) | 0.94 |
| Borderline changes or T-cell mediated rejection in indication biopsies (graft dysfunction) | |||
| Cumulative prevalence at 1 year | 12/60 (20.0%) | 13/70 (18.6%) | 0.84 |
| Cumulative prevalence at 3 years | 16/60 (26.7%) | 20/70 (28.6%) | 0.81 |
| Acute T-cell mediated rejection in protocol biopsies (stable graft function) | |||
| At 6 months | 5/47 (10.6%) | 6/53 (11.3%) | 0.91 |
| At 12 months | 0/35 (0.0%) | 2/46 (4.3%) | 0.21 |
| At 24 months | 0/33 (0.0%) | 2/42 (4.8%) | 0.20 |
| Borderline changes in protocol biopsies (stable graft function) | |||
| At 6 months | 4/47 (8.5%) | 5/53 (9.4%) | 0.87 |
| At 12 months | 6/35 (17.1%) | 2/46 (4.3%) | 0.06 |
| At 24 months | 4/33 (12.1%) | 1/42 (2.4%) | 0.09 |