Everolimus Post OLT

Protocol: 
CRAD001AH181T
Phase: 
II

A single center, open-label, randomized, controlled pilot trial to evaluate the efficacy and safety of everolimus conversion versus standard immunosuppression in liver transplant recipients

The purpose of this study is to evaluate the efficacy of an everolimus conversion (EVR) protocol as compared to the standard tacrolimus (TAC) based protocol in liver transplant recipients, as determined by renal function, rejection rates, and progression to fibrosis (in HCV positive subjects). Additionally, safety profile and tolerability of these regimens will be assessed.

Trial Website: https://clinicaltrials.gov/show/NCT01998789

Are you Eligible? (Inclusion Criteria)

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

Specialty Area(s)

Trial Location

NYP/Columbia
New York, NY 10032
United States