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

• Status: Recruiting
• Trial end date: 2024-02-28
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Fenofibrate

Criteria

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 21-35 (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 0-35 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.