Evaluation of the benefits of Administering immunosuppressive drugs as Single daily doses over the first Year after liver transplantation

transplantation

The primary outcome will be a composite endpoint, named “treatment failure”, defined by the occurrence of any of the following events during the first 6 months (2nd objective) or during the first 18 months (1st objective) after transplantation: • Patient death, • Graft loss, • Biopsy-proven acute rejection, with a rejection activity index score ≥4 according to the Banff criteria

Comparison, between patients on XR-tacrolimus and patients on LCP-tacrolimus, at M18 post-transplantation a. The proportion of deaths b. The proportion of graft losses c. The proportion of biopsy-proven acute rejection with an activity score ≥4, Comparison, between patients the four arms, at M6 andM18 post-transplantation, of: a. The proportion of deaths b. The proportion of graft losses c. The proportion of biopsy-proven acute rejection with an activity score ≥4, Comparison, between patients on XR-tacrolimus and patients on LCP-tacrolimus, at M18 post-transplantation, of: a. The proportion of non-adherent patients b. Mean PCS-QOL and MCS-QOL, Comparison, between patients on XR-tacrolimus and patients on LCP-tacrolimus, at M18 post-transplantation, of the incidence of adverse events of interest, Comparison, between patients on MMF BID and patients on MMF QD , at M18 post-transplantation, of: a. The proportion of non-adherent patients b. Mean PCS-QOL and MCS-QOL c. The incidence of adverse events of interest, Comparison, between the four arms and at each post-transplantation period, of: a. Mean tacrolimus and MPA AUC0-24h, b. Mean tacrolimus C0/dose and AUC0-24h/dose, c. Mean MPA AUC0-24h/dose.

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