Table 3

Results from the Intent to Treat Population for Primary and Secondary Efficacy Variables
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) --

BPAR = biopsy proven acute rejection. CI = confidence interval. AE = adverse event.

a P = 0.010, Fisher’s exact test: high level FK778 vs. MMF. b P = 0.007, Fisher’s exact test: high level FK778 vs. MMF. c Chi-square test.

BPAR treatment outcomes may be reported more than once in the same patient.

Treatment failure was the first occurrence of any of these events.

Wlodarczyk et al.

Wlodarczyk et al. BMC Nephrology 2012 13:68   doi:10.1186/1471-2369-13-68

Open Data