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

Date de début de l'étude : 1 mars 2013

Inclusion Criteria: Patients must give written informed consent before any assessment is performed. MELD ≥ 25. Recipients who are 18-70 years of age of a primary or secondary liver transplant from a deceased donor. 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. Ability and willingness to provide written informed consent and adhere to study regimen. Patients who are able to take oral medication at time of randomization. Glomerular Filtration Rate (GFR) ≥ 30 ml/min. Exclusion Criteria: Patients receiving 3rd transplants Fulminant hepatic failure Living donor transplants Donation after Cardiac Death (DCD) donors or split grafts Active infection or hemodynamic instability at the time of transplant Renal replacement therapy for clearance within 7 days prior to randomization Presence of thrombosis via Doppler ultrasound of the major hepatic arteries, major hepatic veins, portal vein and inferior vena cava. 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. Spot urine protein/creatinine ratio > 1g/24h at time of randomization Combined liver/kidney transplant Patients who have severe hypercholesterolemia (>350 mg/dL) or Patients with platelet count < 50,000 at time of randomization Patients with an Absolute neutrophil count (ANC) of < 1,000 or White Blood Count (WBC) of <2,000 at time of randomization Patients with hemoglobin <6g/dL Patients who are unable to take oral medication at time of randomization Patients with clinically significant systemic infection requiring active use of IV antibiotics, anti-virals, or anti-fungals Patients who are in a critical care setting at the time of randomization requiring life support measures such as mechanical ventilation, dialysis, requirement of vasopressor agents Known intolerance to tacrolimus or everolimus or Myfortic.