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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fenofibrate to Prevent Ischemic Cholangiopathy in Donation After Circulatory Death Liver Transplantation (FICsDCD)

Conditions
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Liver Transplant

Intervention / Treatment
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* Drug: Fenofibrate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recipients of DCD liver transplants<br>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<br>* 160mg once daily orally for 12 weeks<br>* Other names: Lofibra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of fenofibrate | Proportion of subjects to discontinue fenofibrate due to adverse events | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of fenofibrate | Proportion of subjects with a new grade 3 or 4 adverse event | 12 weeks | 
| Safety of fenofibrate | Proportion of subjects with acute cellular rejection during fenofibrate treatment | 12 weeks | 
| Safety of fenofibrate | Mean change in calculated glomerular filtration rate before, during and after fenofibrate treatment | 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 | 4 weeks after end of treatment | 
| Efficacy of fenofibrate | Proportion of subjects who develop IC compared with historical control group | 12 weeks | 
| Serum biomarker association with development of IC | Assess association of 5 serum biomarkers with development of IC | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic Cholangiography