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


About this study

The purpose of this study is to test the tolerability, safety, and effectiveness of 12 weeks once-daily fenofibrate in reducing Ischemic Cholangiopathy (IC) incidence after Donation after Circulatory Death (DCD) liver transplantation. Additionally to assess the association between serum markers of cholestasis and development of IC. Tolerability and safety will be assessed as proportions of: drug discontinuation, and new grade 3 or 4 adverse events. Effectiveness will be assessed as incidence of cholangiographically-diagnosed IC and incidence of any IC-related complication.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated11/21/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Kristopher Croome, M.D.

Open for enrollment

Contact information:

Gina Toma

(480) 574-2754


Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Channa Jayasekera, M.D.

Open for enrollment

Contact information:

Gina Toma

(480) 574-2754


More information


Publications are currently not available

Mayo Clinic Footer