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

Phase 2TerminatedNCT05514119

Mayo Clinic6 enrolled

Overview

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).

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Liver Transplant

Interventions

FenofibrateDRUG

160mg once daily orally for 12 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic Arizona

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Tolerability of Fenofibrate

Proportion of subjects to discontinue fenofibrate due to adverse events

Time frame: 12 weeks

Secondary Outcomes

Safety of Fenofibrate

Proportion of subjects with a new grade 3 or 4 adverse event

Time frame: 12 weeks

Safety of Fenofibrate

Proportion of subjects with acute cellular rejection during fenofibrate treatment

Time frame: 12 weeks

Safety of Fenofibrate

Mean change in calculated glomerular filtration rate before, during and after fenofibrate treatment

Time frame: 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

Time frame: 16 weeks

Efficacy of Fenofibrate

Incidence of ischemic cholangiopathy in those treated with 12 weeks of fenofibrate, compared to a historical control group

Time frame: 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.

Data from ClinicalTrials.gov

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