Myfortic in High MELD Liver Transplantation

Prospective Evaluation of the Efficacy and Safety of Zortress (Everolimus)/Myfortic (Enteric Coated Mycophenolate Sodium) Conversion in High MELD Liver Transplantation

NCT01807767•Medical College of Wisconsin

View on ClinicalTrials.gov

Summary

The objective of the study is to determine the efficacy and safety of Everolimus conversion in liver transplantation. Most large US liver centers transplant patients with high Model for End-Stage Liver Disease (MELD) scores. However, many of the sponsored liver transplant trials in the US do not include patients with high MELD scores making it difficult to extrapolate these trial data to the patients cared for at larger liver transplant centers. The greatest potential benefit of mammalian target of rapamycin (mTOR) inhibitors is the avoidance of the side-effects of calcineurin-inhibitors, namely, renal insufficiency, diabetes and hypertension. Therefore, this protocol is designed to study the efficacy and safety of everolimus and Myfortic in liver transplant patients with high MELD scores at two large centers with a vast experience in the administration of mTOR inhibitors.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must give written informed consent before any assessment is performed.
•1. MELD ≥ 25.
•2. Recipients who are 18-70 years of age of a primary or secondary liver transplant from a deceased donor.
•3. Allograft is functioning at an acceptable level by the time of randomization as defined by the Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin levels ≤3 times Upper Limit of Normal (ULN), and Alkaline Phosphatase (AlkP) levels ≤ 5 times ULN.
•4. Ability and willingness to provide written informed consent and adhere to study regimen.
•5. Patients who are able to take oral medication at time of randomization. Glomerular Filtration Rate (GFR) ≥ 30 ml/min.

Exclusion Criteria

•1. Patients receiving 3rd transplants
•2. Fulminant hepatic failure
•3. Living donor transplants
•4. Donation after Cardiac Death (DCD) donors or split grafts
•5. Active infection or hemodynamic instability at the time of transplant
•6. Renal replacement therapy for clearance within 7 days prior to randomization
•7. Presence of thrombosis via Doppler ultrasound of the major hepatic arteries, major hepatic veins, portal vein and inferior vena cava.
•8. An episode of acute rejection that required antibody therapy or more than one steroid sensitive episode of acute rejection prior to randomization. This includes patients who have not completed steroid treatment for acute rejection within 7 days prior to randomization.
•9. Spot urine protein/creatinine ratio \> 1g/24h at time of randomization
•10. Combined liver/kidney transplant
+7 more criteria

Locations (1)

University of Colorado Denver

Aurora, Colorado, United States

Key Dates

Start Date

March 1, 2013

Primary Completion Date

July 1, 2015

Completion Date

August 1, 2015

Last Updated

October 21, 2019

Conditions

High Model for End-Stage Liver Disease (MELD) Score

Interventions

Everolimus, Myfortic and Tacrolimus

DRUG

Myfortic and Tacrolimus

DRUG