NCT02909335

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• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In the liver transplant, early interruption of calcineurin inhibitors with a quick relay everolimus monotherapy preserves renal function and is associated with a lower acute rejection rate. We wish to assess whether the introduction of a de novo immunosuppression everolimus under protection of basiliximab induction, mycophenolate mofetil and then low doses of corticosteroids, reduces the nephrotoxicity of immunosuppressive therapy in liver transplant patients, compared to a standard protocol with tacrolimus associated with mycophenolate mofetil and low dose corticosteroids.

Conditions

• Liver Transplantation

Interventions

Type	Name	Description
DRUG	Tacrolimus	Tacrolimus is administered at an initial dose of 0.040 mg / kg twice a day on Day 5. The doses are then adjusted to maintain trough levels : * between 6 and 10 ng / ml during the first 2 months, * between 5 and 8 ng / ml from the start of the end M3 and M6, * and between 4 and 6 ng / ml between the beginning and the end of M7 M12.
DRUG	Everolimus	Everolimus is administered at an initial dose of 1.5 mg twice a day on Day 5. The doses are then adjusted to maintain trough levels: * between 6 and 10 ng / ml during the first 2 months, * between 5-8 ng / ml from the start of the end M3 and M6, * and between 4 and 6 ng / ml between the beginning and the end of M7 M12.
DRUG	Mycophenolate mofetil	mycophenolate mofetil is administered similarly in the two groups at the dose of 1.5 g for the first two months and then 1 g twice a day. The doses may be adjusted according to the tolerance of the product.
DRUG	Prednisolone, Prednisone or Methylprednisolone	Corticosteroid is similarly administered in both groups between baseline and the end of M6 and adjusted in case of acute rejection

Timeline

• Start date: 2016-11-01
• Primary completion: 2021-11-01
• Completion: 2021-11-01
• First posted: 2016-09-21
• Last updated: 2022-12-14