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Table 3 Results from the Intent to Treat Population for Primary and Secondary Efficacy Variables

From: A multicenter, randomized, double-blind study comparing different FK778 doses (manitimus) with tacrolimus and steroids vs. MMF with tacrolimus and steroids in renal transplantation

 

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)

--

  1. BPAR = biopsy proven acute rejection. CI = confidence interval. AE = adverse event.
  2. 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.
  3. BPAR treatment outcomes may be reported more than once in the same patient.
  4. Treatment failure was the first occurrence of any of these events.