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Non-inferiority and Tolerance of Conversion From Prograf® to Advagraf® at D7 Versus D90 After Liver Transplantation
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
Details
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 90 |
| Start date | 2014-11 |
| Completion | 2016-10-17 |
Conditions
- Immunosuppression After Liver Transplantation
Interventions
- Conversion at day 7 ± 3 Prograf® to Advagraf®
- Conversion at day 90±5 Prograf® to Advagraf®
Primary outcomes
- First episode of acute rejection during the first 6 months — 6 months
First episode of acute rejection during the first 6 months
Countries
France