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

NCT05514119 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 22-007122
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Liver Transplant

Keywords

Ischemic Cholangiography

Outcome Measures

Primary Outcomes (1)

• Tolerability of Fenofibrate

  Proportion of subjects to discontinue fenofibrate due to adverse events

  12 weeks

Secondary Outcomes (6)

• Safety of Fenofibrate

  12 weeks

• Safety of Fenofibrate

  12 weeks

• Safety of Fenofibrate

  Baseline, treatment weeks 4, 8, 12, and at 4 weeks after end of treatment

• Safety of Fenofibrate

  16 weeks

• Efficacy of Fenofibrate

  12 weeks

Study Arms (1)

Recipients of DCD liver transplants

EXPERIMENTAL

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

Interventions

Fenofibrate DRUG

160mg once daily orally for 12 weeks

Also known as: Lofibra

Recipients of DCD liver transplants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Arizona

Phoenix, Arizona, 85254, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Fenofibrate

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Limitations and Caveats

Study was terminated early due to low enrollment.

Results Point of Contact

• Title: Channa Jayasekera, M.D.
• Organization: Mayo Clinic

jayasekera.channa@mayo.edu

480-342-1095

Study Officials

• Channa Jayasekera, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 24, 2022
• Study Start: August 17, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 1, 2024
• Last Updated: October 22, 2025
• Results First Posted: October 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)