Efficacy of Certican® in Combination With Myfortic® in Renal
Status:
Unknown status
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
The primary objective is to demonstrate the superiority of everolimus plus Myfortic® plus
corticosteroids following CNI withdrawal at week 16 compared to tacrolimus plus Myfortic®
plus corticosteroids as measured by the change in calculated Glomerular Filtration Rate
(cGFR) from baseline to month 12.
The key secondary objective is to demonstrate non-inferiority of biopsy-proved acute
rejection (BPAR), graft loss, death or loss to follow-up (composite endpoint) at month 12 in
patients switched to everolimus plus Myfortic® plus corticosteroids following CNI withdrawal
at Week 16 compared to patients maintained on tacrolimus plus Myfortic® plus corticosteroids.
Patients will be submitted to monthly GFR determination but, for group comparison, only the
GFR measured at month 12 and month 24 of renal transplantation will be used.