Everolimus Post OLT

Inclusion Criteria:

• Ability and willingness to provide informed consent and adhere to study regimen
• Recipients of primary liver transplant from deceased or living donor
• 18 years of age or greater
• Lab Model For End-Stage Liver Disease (MELD) score ≤ 30
• Abbreviated Modification of Diet in Renal Disease (MDRD) eGFR ≥ 30 mL/min/1.73

Exclusion Criteria:

Key Exclusion

• Recipient of multiple solid or organ transplant, or have previously received and organ transplant
• Women of child-bearing potential unless they are willing to participate in adequate contraception methods as outlined in the study.

Key Exclusion-Baseline/ Randamization

• Severe hypercholesterolemia (> 350 mg/dL) or hypertriglyceridemia (> 500 mg/dL) within 30 days prior to baseline.
• Thrombocytopenia (platelets < 50,000/mm3)
• Subjects in a critical care unit requiring life support measures such as mechanical ventilation, dialysis, requirement of vasopressor agents
• Liver allograft is functioning at an unacceptable level as defined by the Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin levels > 3 times upper limit of normal (ULN) and Alkaline Phosphatase (AlkP) and Gamma-glutamyltransferase (GGT) levels > 5 times ULN
• Hepatocellular carcinoma with evidence of microvascular or macrovesicular invasion on explanted liver
• Inability to take medications by mouth
• Renal insufficiency, as defined by abbreviated MDRD eGFR < 30 mL/min/1.73m2, or requirement of dialysis, that does not recover prior to baseline
• Episode of acute rejection requiring antibody therapy or more than one steroid treated episode of acute rejection
• Subtherapeutic trough levels of tacrolimus during the week prior to baseline (subject must have at least one tacrolimus level ≥ 8 ng/mL)
• The presence of thrombosis via Doppler ultrasound of the major hepatic arteries, major hepatic veins, portal vein and inferior vena cava.
• Presence of clinically significant wound