Clinical Trials Logo
  1. Home
  2. Other
  3. 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 — FOREVER  

Liver Transplantation Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02909335
Study type Interventional
Source Rennes University Hospital
Contact
Status Withdrawn
Phase Phase 3
Start date November 2016
Completion date November 2021
View Details
See also
  Status Clinical Trial Phase
Completed NCT04180735 - Intestinal Perforation in Patients Receiving an Orthtopic Liver Transplantation in the Montpellier University Hospital
Completed NCT01011205 - Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation Phase 3
Completed NCT01888432 - Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants Phase 3
Recruiting NCT04203004 - HOPE With Cytokine Filtration in Liver Transplantation (Cyto-HOPE) N/A
Recruiting NCT04564313 - Safety and Efficacy of Camrelizumab (Anti-PD-1 Antibody) in Recurrent HCC After Liver Transplantation Phase 1
Withdrawn NCT03596970 - Study of the Effect of Everolimus Immunosuppressive Combination Therapies on Renal Function When Used as a Maintenance Treatment for Liver Transplant Patients. Phase 3
Not yet recruiting NCT02544906 - Propofol Versus Dexmedetomidine for Prevention of Sevoflurane Agitation in Recipients of Living Donor Liver Transplantation N/A
Completed NCT03133065 - Early Treatment of Recurrent HCV- Infection Post Liver Transplantation in the Era of DAAs Phase 4
Recruiting NCT01705015 - Organ Transplantation Rehabilitation: Effect of Bedside Exercise Device and Activity Reinforcement N/A
Completed NCT01425385 - Autoregulation Assessment During Liver Transplantation N/A
Terminated NCT01445236 - Pilot Study of Immunosuppression Drug Weaning in Liver Recipients Exhibiting Biomarkers of High Likelihood of Tolerance N/A
Completed NCT01655563 - Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation Phase 2
Completed NCT00938860 - Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C Phase 4
Completed NCT00531921 - Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival N/A
Terminated NCT00585858 - Cytokine Kinetics Test to Assess the Presence or Absence of Tolerance in Organ Transplant N/A
Withdrawn NCT00585429 - Evaluation of Kidney Disease in Liver Transplant Recipients N/A
Completed NCT00456235 - Reduction in the Risk of Rejection by Mycophenolate Mofetil Dose Adjustment in Liver Transplant Patients With Side Effects Caused by the Calcineurine Inhibitors Phase 4
Recruiting NCT00147459 - Immunogenicity of Booster Hepatitis B Vaccines in Children After Liver Transplantation N/A
Withdrawn NCT00167492 - Enteric Coated Myfortic for Liver Transplant Recipients Phase 4
Terminated NCT00161356 - Ambisome in Liver Transplant Patients Phase 4