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

Liver Transplant Clinical Trial

— FICsDCD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05514119
• Other study ID #: 22-007122
• Status: Recruiting
• Phase: Phase 2
• Start date: August 17, 2022
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Liver Transplant

Intervention

Drug:
• Fenofibrate
160mg once daily orally for 12 weeks

Locations

Country	Name	City	State
United States	Mayo Clinic Arizona	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability of fenofibrate	Proportion of subjects to discontinue fenofibrate due to adverse events	12 weeks
Secondary	Safety of fenofibrate	Proportion of subjects with a new grade 3 or 4 adverse event	12 weeks
Secondary	Safety of fenofibrate	Proportion of subjects with acute cellular rejection during fenofibrate treatment	12 weeks
Secondary	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
Secondary	Safety of fenofibrate	Proportion of subjects myopathy confirmed by serum creatine kinase elevation	4 weeks after end of treatment
Secondary	Efficacy of fenofibrate	Proportion of subjects who develop IC compared with historical control group	12 weeks
Secondary	Serum biomarker association with development of IC	Assess association of 5 serum biomarkers with development of IC	12 weeks

External Links

•   Mayo Clinic Clinical Trials