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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

NCT02909335 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2022-12-14

No results posted yet for this study

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.

Conditions

  • Liver Transplantation

Interventions

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

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Karim BOUDJEMA, MD, PhD · CHU Rennes

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2021-11-30
Completion
2021-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02909335 on ClinicalTrials.gov