Clinical Study

Long-Term Impact of Cyclosporin Reduction with MMF Treatment in Chronic Allograft Dysfunction: REFERENECE Study 3-Year Follow Up

Table 3

Renal dysfunction.

Randomization
population1
On-treatment
population2
Total
MMF group3
(n=48)
Control group4
(n=22)
Group I5
(n=56)
Group II6
(n=14)
(n=70)
Number of events12615318

 Increased serum creatinine7 (58.3%)2 (33.3%)8 (53.3%)1 (33.3%)9 (50%)
 Acute rejection (biopsy proven)0 (0%)1 (16.7%)1 (6.7%)0 (0%)1 (5.6%)
 Chronic allograft nephropathy (biopsy proven)3 (25%)3 (50%)4 (26.7%)2 (66.7%)6 (33.3%)
 Recurrence of initial nephropathy1 (8.3%)0 (0%)1 (6.7%)0 (0%)1 (5.6%)
 Others1 (8.3%)0 (0%)1 (6.7%)0 (0%)1 (5.6%)
Patients with at least one episode of renal dysfunction8 (16.7%)5 (22.7%)10 (17.9%)3 (21.4%)13 (18.6%)

1 Patients randomized to receive either MMF or CsA treatment in the initial study phase.
2 Determined by the treatment patients received at the end of the post-trial phase (mycophenolic acid derivative or not).
3 Patients who received 2 g MMF per day and 50% of the initial CsA dose.
4 Patients who received the usual CsA dose.
5 Patients who received a treatment with a mycophenolic acid derivative at the end of the follow up phase.
6 Patients without a mycophenolic acid derivative at the end of the follow up phase.