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

Phase 2

Completed

• Conditions: Liver Transplant
• Interventions: Drug: Fenofibrate

• Registration Number: NCT05514119
• Lead Sponsor: Mayo Clinic

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).

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 Timeline

• Study Start: 2022-08-17
• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-23
• Study First Posted: 2022-08-24
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Recipients of DCD liver transplants	Fenofibrate	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

Primary Outcome Measures

Name	Time	Method
Tolerability of fenofibrate	12 weeks	Proportion of subjects to discontinue fenofibrate due to adverse events

Secondary Outcome Measures

Name	Time	Method
Serum biomarker association with development of IC	12 weeks	Assess association of 5 serum biomarkers with development of IC
Safety of fenofibrate	4 weeks after end of treatment	Proportion of subjects myopathy confirmed by serum creatine kinase elevation
Efficacy of fenofibrate	12 weeks	Proportion of subjects who develop IC compared with historical control group

Trial Locations

Locations (1)

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States