Conversion Prograf® to Advagraf® at D7 Versus D90 After Liver Transplantation
Status:
Completed
Trial end date:
2016-10-17
Target enrollment:
Participant gender:
Summary
The best period for the conversion from Prograf (tacrolimus administered twice daily) to
Advagraf (once-daily prolonged-release tacrolimus) remains unknown. The aim of this
prospective, randomized, multicenter trial is to prove the non-inferiority of the early
conversion (at D7) versus the conversion at D90 after liver transplantation. The primary
objective will be to evaluate the incidence of a first biopsy-proven acute rejection in the 6
first months, and prove the non-inferiority of the conversion at D7 + / - 3 versus the
conversion at D90 + / - 5 (reference group). If non-inferiority is proved, the two strategies
will be compared in terms of superiority. 250 patients will be included. Three ancillary
studies will be added : a PK study in a subgroup of 40 patients (20 patients per arm), an
assay of the calcineurin activity on a subgroup of 40 patients, and a medicoeconomic study in
all patients