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

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05514119
Collaborator
(none)
148
Enrollment
1
Location
1
Arm
18.4
Anticipated Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
148 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Fenofibrate to Prevent Ischemic Cholangiopathy in Donation After Circulatory Death Liver Transplantation (FICsDCD)
Actual Study Start Date :
Aug 17, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Recipients of DCD liver transplants

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
160mg once daily orally for 12 weeks
Other Names:
  • Lofibra

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Tolerability of fenofibrate [12 weeks]

      Proportion of subjects to discontinue fenofibrate due to adverse events

    Secondary Outcome Measures

    1. Safety of fenofibrate [12 weeks]

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

    2. Safety of fenofibrate [12 weeks]

      Proportion of subjects with acute cellular rejection during fenofibrate treatment

    3. Safety of fenofibrate [Baseline, treatment weeks 4, 8, 12, and at 4 weeks after end of treatment]

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

    4. Safety of fenofibrate [4 weeks after end of treatment]

      Proportion of subjects myopathy confirmed by serum creatine kinase elevation

    5. Efficacy of fenofibrate [12 weeks]

      Proportion of subjects who develop IC compared with historical control group

    6. Serum biomarker association with development of IC [12 weeks]

      Assess association of 5 serum biomarkers with development of IC

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 21-35 (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 0-35 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Arizona Phoenix Arizona United States 85254

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Channa Jayasekera, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Channa R Jayasekera, MD, MSc, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05514119
    Other Study ID Numbers:
    • 22-007122
    First Posted:
    Aug 24, 2022
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Channa R Jayasekera, MD, MSc, Principal Investigator, Mayo Clinic
    Ischemic Cholangiography
    Additional relevant MeSH terms:
    Ischemia
    Fenofibrate

    Study Results

    No Results Posted as of Aug 24, 2022