Back to resultsA Study to Assess the Role of Fenofibrate in Preventing Ischemic Cholangiopathy After Liver Transplantation (FICsDCD)
Primary Purpose
Liver Transplant
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fenofibrate
Sponsored by
About this trial
This is an interventional treatment trial for Liver Transplant focused on measuring Ischemic Cholangiography
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic ArizonaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Recipients of DCD liver transplants
Arm Description
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
Outcomes
Primary Outcome Measures
Tolerability of fenofibrate
Proportion of subjects to discontinue fenofibrate due to adverse events
Secondary Outcome Measures
Safety of fenofibrate
Proportion of subjects with a new grade 3 or 4 adverse event
Safety of fenofibrate
Proportion of subjects with acute cellular rejection during fenofibrate treatment
Safety of fenofibrate
Mean change in calculated glomerular filtration rate before, during and after fenofibrate treatment
Safety of fenofibrate
Proportion of subjects myopathy confirmed by serum creatine kinase elevation
Efficacy of fenofibrate
Proportion of subjects who develop IC compared with historical control group
Serum biomarker association with development of IC
Assess association of 5 serum biomarkers with development of IC
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05514119
Brief Title
A Study to Assess the Role of Fenofibrate in Preventing Ischemic Cholangiopathy After Liver Transplantation
Acronym
FICsDCD
Official Title
Fenofibrate to Prevent Ischemic Cholangiopathy in Donation After Circulatory Death Liver Transplantation (FICsDCD)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplant
Keywords
Ischemic Cholangiography
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
148 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Recipients of DCD liver transplants
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Fenofibrate
Other Intervention Name(s)
Lofibra
Intervention Description
160mg once daily orally for 12 weeks
Primary Outcome Measure Information:
Title
Tolerability of fenofibrate
Description
Proportion of subjects to discontinue fenofibrate due to adverse events
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Safety of fenofibrate
Description
Proportion of subjects with a new grade 3 or 4 adverse event
Time Frame
12 weeks
Title
Safety of fenofibrate
Description
Proportion of subjects with acute cellular rejection during fenofibrate treatment
Time Frame
12 weeks
Title
Safety of fenofibrate
Description
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
Title
Safety of fenofibrate
Description
Proportion of subjects myopathy confirmed by serum creatine kinase elevation
Time Frame
4 weeks after end of treatment
Title
Efficacy of fenofibrate
Description
Proportion of subjects who develop IC compared with historical control group
Time Frame
12 weeks
Title
Serum biomarker association with development of IC
Description
Assess association of 5 serum biomarkers with development of IC
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Channa Jayasekera, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Latasha Bunkley
Phone
480-792-5756
Email
Bunkley.Latasha@Mayo.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study to Assess the Role of Fenofibrate in Preventing Ischemic Cholangiopathy After Liver Transplantation
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