Clinical Study

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

Table 1

Study withdrawal and reason for withdrawal.

Randomization population1On-treatment population2Total
MMF group3(n=48)Control group4(n=22)Group I5(n=56)Group II6(n=14)(n=70)

Study withdrawal5 (10.4%)3 (13.6%)7 (12.5%)1 (7.1%)8 (11.4%)
Graft loss2 (4.2%)2 (9.1%)3 (5.4%)1 (7.1%)4 (5.7%)
P-value7.5851.000
Death0 (0%)1 (4.5%)1 (4.5%)0 (0%)1 (1.4%)
Other83 (6.3%)0 (0%)3 (5.4%)0 (0%)3 (4.3%)

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.
7 1 patient moved, 2 patients did not perform visit at month 60.
8 Comparison between groups of patients who had graft loss.