High level FK778 | Mid level FK778 | Low level FK778 | MMF | |
---|---|---|---|---|
N = 87 | N = 92 | N = 92 | N = 93 | |
at week 24 | ||||
BPAR (local evaluation), n (%) | 30 (34.5) a | 27 (29.3) | 21 (22.8) | 16 (17.2) a |
at month 12 | ||||
Acute rejection | 35 (40.2) | 32 (34.8) | 32 (34.8) | 21 (22.6) |
BPAR (local evaluation), n (%) | 30 (34.5) | 29 (31.5) | 22 (23.9) | 18 (19.4) |
Treatment outcome: | ||||
Steroid resistant | 15 (17.2) b | 11 (12) | 10 (10.9) | 4 (4.3) b |
Steroid sensitive | 16 (18.4) | 19 (20.7) | 13 (14.1) | 14 (15.1) |
Histological grade: | ||||
Mild (Banff I) | 9 (10.3) | 21 (22.8) | 9 (9.8) | 6 (6.5) |
Moderate (Banff II) | 20 (23) | 8 (8.7) | 13 (14.1) | 12 (12.9) |
Severe (Banff III) | 1 (1.1) | 0 | 0 | 0 |
Difference (CI) in BPAR: FK778 vs. MMF | 0.151 | 0.122 | 0.046 | -- |
(0.023; 0.279) | (-0.003; 0.246) | (-0.073; 0.164) | ||
BPAR (central evaluation), n (%) | 23 (26.4) | 23 (25) | 16 (17.4) | 16 (17.2) |
Treatment failure, n (%) | 46 (52.9) | 47 (51.1) | 34 (37) | 29 (31.2) |
BPAR (local evaluation) | 28 (32.2) | 28 (30.4) | 21 (22.8) | 18 (19.4) |
Graft loss | 7 (8) | 8 (8.7) | 4 (4.3) | 5 (5.4) |
Withdrawal due to AE | 9 (10.3) | 10 (10.9) | 9 (9.8) | 5 (5.4) |
Withdrawal due to lack of | 2 (2.3) | 1 (1.1) | 0 | 1 (1.1) |
efficacy | ||||
Estimated treatment failure survival rate | 0.46 | 0.46 | 0.63 | 0.69 |
Estimated treatment failure survival rate: FK778 vs. MMFc | 9.65 (P = 0.002) | 5.66 (P = 0.017) | 0.54 (P = 0.46) | -- |