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

Fenofibrate to Prevent Ischemic Cholangiopathy in Donation After Circulatory Death Liver Transplantation (FICsDCD)

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).

Study Overview

• Status: Terminated
• Conditions: Liver Transplant
• Intervention / Treatment: Drug: Fenofibrate

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85254
      • Mayo Clinic Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.
• Adults lacking capacity to consent to treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Fenofibrate; 160mg once daily orally for 12 weeks; Other Names: Lofibra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerability of Fenofibrate	Proportion of subjects to discontinue fenofibrate due to adverse events	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Fenofibrate	Proportion of subjects with a new grade 3 or 4 adverse event	12 weeks
Safety of Fenofibrate	Proportion of subjects with acute cellular rejection during fenofibrate treatment	12 weeks
Safety of Fenofibrate	Mean change in calculated glomerular filtration rate before, during and after fenofibrate treatment	Baseline, treatment weeks 4, 8, 12, and at 4 weeks after end of treatment
Safety of Fenofibrate	Proportion of subjects myopathy confirmed by serum creatine kinase elevation	16 weeks
Efficacy of Fenofibrate	Incidence of ischemic cholangiopathy in those treated with 12 weeks of fenofibrate, compared to a historical control group	12 weeks
The Number of Participants Who Developed Ischemic Cholangiopathy (IC)	The number of participants who developed IC was assessed by measuring serum alkaline phosphatase, gamma glutamyl transferase, total bile acid level, fibroblast growth factor 19 level, and 7-alpha-hydroxy-cholesten-4 levels. Logistics regression was used to calculate the changes in serum alkaline phosphatase, gamma glutamyl transferase, total bile acid level, fibroblast growth factor 19 level, and 7-alpha-hydroxy-cholesten-4 and estimate the probability that a participant had developed IC. The probability can range from 0 (no development of IC) to 1 (development of IC), with a higher number indicating a worse outcome.	12 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Channa Jayasekera, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Estimated): October 22, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Ischemic Cholangiography
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia; Organic Chemicals; Ethers; Hydrocarbons; Hydrocarbons, Cyclic; Acids, Acyclic; Carboxylic Acids; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Butyrates; Phenyl Ethers; Ketones; Fibric Acids; Isobutyrates; Benzophenones; Fenofibrate
• Other Study ID Numbers: 22-007122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No