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

Last updated: April 10, 2025
Sponsor: Mayo Clinic
Overall Status: Completed

Phase

2

Condition

Occlusions

Treatment

Fenofibrate

Clinical Study ID

NCT05514119
22-007122
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who have undergone Donation after Circulatory Death (DCD) livertransplantation (LT).

  • At least one serum alkaline phosphatase level >2.5x upper limit of normal betweenpost-LT days 21-60 (inclusive).

Exclusion

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.

Study Design

Total Participants: 5
Treatment Group(s): 1
Primary Treatment: Fenofibrate
Phase: 2
Study Start date:
August 17, 2022
Estimated Completion Date:
December 01, 2024

Study 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.

Connect with a study center

  • Mayo Clinic Arizona

    Phoenix, Arizona 85254
    United States

    Site Not Available

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