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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
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 • NCT030018171%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received a liver transplant from a donor after circulatory death.My kidney function is low, with a filtration rate under 30 ml/min.I had a liver transplant for bile duct or liver inflammation.I have an untreated blockage or narrowing in my liver's artery.I have a bile duct issue not treated within 2 months after liver transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Recipients of DCD liver transplants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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