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

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Liver Transplant

Treatments: Drug: Fenofibrate

Study type: Interventional

Funder types: Other

Identifiers

NCT05514119

22-007122

Details and patient eligibility

About

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).

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

5 participants in 1 patient group

Recipients of DCD liver transplants

Experimental group

Description:

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

Treatment:

Drug: Fenofibrate