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Fibrate

Fenofibrate for Ischemic Cholangiopathy After Liver Transplant (FICsDCD Trial)

Phase 2
Recruiting
Led By Channa Jayasekera, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

This trial will study whether a daily medication can prevent a complication during a medical procedure for people who have received transplanted livers from deceased donors.

Who is the study for?
This trial is for patients who've had a liver transplant from a donor after circulatory death and have high alkaline phosphatase levels. It's not for those with certain liver diseases, untreated hepatic artery issues, severe kidney problems, significant other illnesses or psychiatric conditions that could affect the study, or known allergies to fenofibrate.
What is being tested?
The study tests if taking fenofibrate daily can prevent ischemic cholangiopathy in people who received liver transplants from donors after circulatory death. The goal is to see if this medication improves safety and effectiveness compared to standard care without it.
What are the potential side effects?
Fenofibrate may cause side effects like digestive discomfort, potential liver enzyme changes, muscle pain or weakness, and possible interactions with other drugs. Rarely it can lead to more serious issues such as inflammation of the pancreas or gallstones.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tolerability of fenofibrate
Secondary outcome measures
Efficacy of fenofibrate
Safety of fenofibrate
Serum biomarker association with development of IC

Side effects data

From 2019 Phase 3 trial • 551 Patients • NCT03001817
1%
Nasopharyngitis
1%
Angina unstable
100%
80%
60%
40%
20%
0%
Study treatment Arm
K-877 and Fenofibrate Placebo: 40-Week Extension
K-877: 12-Week Efficacy
Placebo: 12-Week Efficacy
Fenofibrate and K-877 Placebo: 40-Week Extension

Trial Design

1Treatment groups
Experimental Treatment
Group I: Recipients of DCD liver transplantsExperimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Fenofibrate
2018
Completed Phase 4
~6500

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,297 Total Patients Enrolled
Channa Jayasekera, MDPrincipal InvestigatorMayo Clinic

Media Library

Fenofibrate (Fibrate) Clinical Trial Eligibility Overview. Trial Name: NCT05514119 — Phase 2
Liver Transplant Research Study Groups: Recipients of DCD liver transplants
Liver Transplant Clinical Trial 2023: Fenofibrate Highlights & Side Effects. Trial Name: NCT05514119 — Phase 2
Fenofibrate (Fibrate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05514119 — Phase 2
~49 spots leftby Sep 2025
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