Conversion Prograf® to Advagraf® at D7 Versus D90 After Liver Transplantation

• Status: Completed
• Trial end date: 2016-10-17
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Tacrolimus

Criteria

Inclusion Criteria :

• 18 to 75 years

• First liver transplantation

• No contra-indication to tacrolimus, mycophenolate mofetil or steroids

• Informed consent signed

• French Health Assurance

Exclusion Criteria :

• Combined transplantation

• Severe uncontrolled infection

• Hypersensitivity to tacrolimus or its excipients, to other macrolides, to mycophenolate mofetil or its excipients

• Pregnant or lactating woman, or women of childbearing potential without adequate method of contraception

• Cancer or pasthistory of cancer other than basal or squamous cell carcinoma or hepatocellular carcinoma suitable for liver transplantation

• Patients with renal impairment where GFR is less than 30ml/min

• HIV positivity