A Study to Assess the Role of Fenofibrate in Preventing Ischemic Cholangiopathy After Liver Transplantation

Overview

The purpose of this study is to evaluate the safety and effectiveness of a once-daily medication, fenofibrate (Lofibra), to prevent ischemic cholangiography (IC) in persons who were transplanted with livers donated after circulatory death (DCD).

Full Title of Study: “Fenofibrate to Prevent Ischemic Cholangiopathy in Donation After Circulatory Death Liver Transplantation (FICsDCD)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2024

Detailed Description

In this prospective pilot study, we aim to evaluate 1) the tolerability and safety, 2) the efficacy of 12 weeks once-daily fenofibrate in reducing IC incidence after DCD liver transplantation, 3) assess the association between serum markers of cholestasis and development of IC.

Interventions

  • Drug: Fenofibrate
    • 160mg once daily orally for 12 weeks

Arms, Groups and Cohorts

  • Experimental: Recipients of DCD liver transplants
    • Subjects that have undergone transplant of a liver donation after circulatory death (DCD) in the last 21-35 days will receive a 12 week fenofibrate (Lofibra) for a duration of 12 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Tolerability of fenofibrate
    • Time Frame: 12 weeks
    • Proportion of subjects to discontinue fenofibrate due to adverse events

Secondary Measures

  • Safety of fenofibrate
    • Time Frame: 12 weeks
    • Proportion of subjects with a new grade 3 or 4 adverse event
  • Safety of fenofibrate
    • Time Frame: 12 weeks
    • Proportion of subjects with acute cellular rejection during fenofibrate treatment
  • Safety of fenofibrate
    • Time Frame: Baseline, treatment weeks 4, 8, 12, and at 4 weeks after end of treatment
    • Mean change in calculated glomerular filtration rate before, during and after fenofibrate treatment
  • Safety of fenofibrate
    • Time Frame: 4 weeks after end of treatment
    • Proportion of subjects myopathy confirmed by serum creatine kinase elevation
  • Efficacy of fenofibrate
    • Time Frame: 12 weeks
    • Proportion of subjects who develop IC compared with historical control group
  • Serum biomarker association with development of IC
    • Time Frame: 12 weeks
    • Assess association of 5 serum biomarkers with development of IC

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who have undergone Donation after Circulatory Death (DCD) liver transplantation (LT). – At least one serum alkaline phosphatase level >2.5x upper limit of normal between post-LT days 21-60 (inclusive). Exclusion criteria:

  • LT performed for primary sclerosing cholangitis or primary biliary cholangitis. – Untreated hepatic artery compromise (e.g thrombosis, stenosis) – Untreated biliary anastomotic stricture or bile leak between days 0-60 after LT – Renal dysfunction defined as baseline glomerular filtration rate < 30 ml/min. – Previously known intolerance or allergy to fenofibrate. – Other clinically significant comorbid condition, including psychiatric conditions, which in the opinion of the study team, may interfere with patient treatment, safety, assessment, or compliance with the treatment.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Channa R Jayasekera, MD, MSc, Principal Investigator – Mayo Clinic
  • Overall Official(s)
    • Channa Jayasekera, MD, Principal Investigator, Mayo Clinic

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