De Novo Everolimus Versus Tacrolimus in Combination With Mofetil Mycophenolate and Low Dose Corticosteroids to Reduce Tacrolimus Induced Nephrotoxicity in Liver Transplantation: a Prospective, Multicentric, Randomised Study

• Status: Unknown status
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Tacrolimus is a calcineurin inhibitor. This is the immunosuppression of reference for patients undergoing a first liver transplant. This treatment can prevent graft rejection, but can cause side effects including kidney failure (in 25% after the first year).

Everolimus is an immunosuppressive that effectively prevents acute rejection in heart and kidney transplant recipients. It preserves renal function when it is started soon after the transplant, i.e. before a severe dysfunction is installed.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rennes University Hospital
• Treatments: Everolimus; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Mycophenolate mofetil; Mycophenolic Acid; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone; Sirolimus; Tacrolimus

Criteria

Pre-transplantation Inclusion Criteria:

• Adults (≥18 years), male or female,

• Patients due to receive a first liver transplant with a full or reduced graft taken from a donor brain-dead beating heart or a related living donor,

• Patients having given a free and informed written consent .

Post-transplantation Inclusion criteria: Patients meeting the following criteria will be included:

• Receiving basiliximab (Simulect)

• Whose immunosuppression regimen from day 5 could immediately consist of either tacrolimus or everolimus, in combination with mycophenolate mofetil and low dose corticosteroids

• With hepatic artery permeable to echo Doppler 4 days after transplant.

Exclusion Criteria:

• History of immunosuppressive therapy,

• Known hypersensitivity to the treatments or macrolides,

• HIV infection

• Autoimmune hepatitis,

• Primary sclerosing cholangitis,

• Programming or realization of a combined transplant,

• Pregnancy or lack of effective contraception,

• Breastfeeding.

• Incompatibility with the donor,

• Thrombosis of the hepatic artery between D0 and D4,

• Non-primary graft function leading to a re-registration on the waiting list.