Table 2.
Primary outcomes
| Using Banff 2015 Classification | Intervention Arm | Control Arm | RR (95% CI); P Value |
|---|---|---|---|
| Intention-to-treat analysis (n=241) | n=120 | n=121 | |
| Combined end point | 61 (51%) | 59 (49%) | 1.04 (0.81 to 1.34); 0.80 |
| Death-censored graft loss within first year | 1 (1%) | 3 (2%) | 0.34 (0.04 to 3.19); 0.62 |
| Clinical rejection day 30–1 yr | 16 (13%) | 17 (14%) | 0.95 (0.50 to 1.79); 1.00 |
| Acute rejection in 1-yr surveillance biopsy (n=201) | 46 (45%) | 38 (38%) | 1.17 (0.85 to 1.63); 0.39 |
| Chronic active TCMR in 1-yr surveillance biopsy (n=201) | 6 (6%) | 8 (8%) | 0.73 (0.26 to 2.02); 0.59 |
| De novo HLA-DSA at 1 yr (n=232) | 6 (5%) | 4 (3%) | 1.50 (0.43 to 5.18); 0.75 |
| eGFR <25 ml/min at 1 yr (n=232) | 1 (1%) | 4 (3%) | 0.25 (0.03 to 2.20); 0.37 |
| Modified intention-to-treat analysis (n=201) | n=102 | n=99 | |
| Combined end point | 58 (57%) | 50 (51%) | 1.13 (0.87 to 1.46); 0.40 |
| Clinical rejection day 30–1 yr | 13 (13%) | 12 (12%) | 1.05 (0.50 to 2.19); 1.00 |
| Acute rejection in 1-yr surveillance biopsy | 46 (45%) | 38 (38%) | 1.17 (0.85 to 1.63); 0.39 |
| Chronic active TCMR in 1-yr surveillance biopsy | 6 (6%) | 8 (8%) | 0.73 (0.26 to 2.02); 0.59 |
| De novo HLA-DSA at 1 yr | 6 (6%) | 3 (3%) | 1.94 (0.50 to 7.55); 0.50 |
| eGFR<25 ml/min at 1 yr | 1 (1%) | 2 (2%) | 0.49 (0.04 to 5.27); 0.62 |
| Per-protocol analysis (n=175) | n=82 | n=93 | |
| Combined end point | 45 (55%) | 46 (49%) | 1.11 (0.84 to 1.47); 0.54 |
| Clinical rejection day 30 to 1 yr | 10 (12%) | 10 (11%) | 1.13 (0.50 to 2.59); 0.81 |
| Acute rejection in 1-yr surveillance biopsy | 37 (45%) | 35 (38%) | 1.20 (0.84 to 1.71); 0.36 |
| Chronic active TCMR in 1-yr surveillance biopsy | 4 (5%) | 8 (9%) | 0.57 (0.18 to 1.81); 0.38 |
| De novo HLA-DSA at 1 yr | 5 (6%) | 3 (3%) | 1.89 (0.47 to 7.67); 0.48 |
| eGFR <25 ml/min at 1 yr | 1 (1%) | 1 (1%) | 1.13 (0.07 to 17.85); 1.00 |
| Using Banff 2019 Classification | |||
|---|---|---|---|
| Intention-to-treat analysis (n=241) | n=120 | n=121 | |
| Combined end point | 27 (23%) | 29 (24%) | 0.94 (0.59 to 1.49); 0.88 |
| Clinical rejection day 30–1 yr | 8 (7%) | 9 (7%) | 0.89 (0.36 to 2.25); 1.00 |
| Acute rejection in 1-yr surveillance biopsy (n=201) | 11 (11%) | 9 (9%) | 1.19 (0.51 to 2.74); 0.81 |
| Modified intention-to-treat analysis (n=201) | n=102 | n=99 | |
| Combined end point | 25 (25%) | 21 (21%) | 1.16 (0.69 to 1.92); 0.62 |
| Clinical rejection day 30–1 yr | 6 (6%) | 5 (5%) | 1.16 (0.37 to 3.69); 1.00 |
| Acute rejection in 1-yr surveillance biopsy | 11 (11%) | 9 (9%) | 1.19 (0.51 to 2.73); 0.81 |
| Per-protocol analysis (n=175) | n=82 | n=93 | |
| Combined end point | 19 (23%) | 20 (22%) | 1.08 (0.62 to 1.87); 0.86 |
| Clinical rejection day 30–1 yr | 5 (6%) | 5 (5%) | 1.13 (0.34 to 3.78); 1.00 |
| Acute rejection in 1-yr surveillance biopsy | 8 (10%) | 9 (10%) | 1.01 (0.41 to 2.49); 1.00 |
Data are given as count (percentage). P-values are calculated by two-tailed Fisher exact test. CI, confidence interval; TCMR, T-cell–mediated rejection; HLA-DSA, donor-specific HLA antibodies.