NCT05514119: FICsDCD

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

Terminated Phase 2 Results posted Last updated 22 October 2025

What this trial tests

Phase 2 trial testing Fenofibrate in Liver Transplant in 6 participants. Terminated before completion.

Timeline

17 August 2022

Primary endpoint
30 June 2024

1 December 2024

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	17 August 2022
Primary completion	30 June 2024
Estimated completion	1 December 2024
Sites	1 location across United States

Drugs / interventions tested

• Fenofibrate (FENOFIBRATE) — full drug profile →

Conditions studied

• Liver Transplant — all drugs for Liver Transplant →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Liver Transplant. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Tolerability of Fenofibrate Primary · 12 weeks

Proportion of subjects to discontinue fenofibrate due to adverse events

Group	Value	95% CI
Recipients of DCD liver transplants	0

Safety of Fenofibrate Secondary · 12 weeks

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

Group	Value	95% CI
Recipients of DCD liver transplants	0

Safety of Fenofibrate Secondary · 12 weeks

Proportion of subjects with acute cellular rejection during fenofibrate treatment

Group	Value	95% CI
Recipients of DCD liver transplants	0

Safety of Fenofibrate Secondary · 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

Baseline

Group	Value	95% CI
Recipients of DCD liver transplants	75.3	± 13.0

Treatment Week 4

Group	Value	95% CI
Recipients of DCD liver transplants	62.7	± 24.2

Treatment Week 8

Group	Value	95% CI
Recipients of DCD liver transplants	62.2	± 26.5

Treatment Week 12

Group	Value	95% CI
Recipients of DCD liver transplants	51.4	± 21.7

Post Treatment Week 4

Group	Value	95% CI
Recipients of DCD liver transplants	60.5	± 19.6

Safety of Fenofibrate Secondary · 16 weeks

Proportion of subjects myopathy confirmed by serum creatine kinase elevation

Group	Value	95% CI
Recipients of DCD liver transplants	0

Efficacy of Fenofibrate Secondary · 12 weeks

Incidence of ischemic cholangiopathy in those treated with 12 weeks of fenofibrate, compared to a historical control group

Group	Value	95% CI
Liver transplant recipients treated with fenofibrate	0

The Number of Participants Who Developed Ischemic Cholangiopathy (IC) Secondary · 12 weeks

The number of participants who developed IC was assessed by measuring serum alkaline phosphatase, gamma glutamyl transferase, total bile acid level, fibroblast growth factor 19 level, and 7-alpha-hydroxy-cholesten-4 levels. Logistics regression was used to calculate the changes in serum alkaline phosphatase, gamma glutamyl transferase, total bile acid level, fibroblast growth factor 19 level, and 7-alpha-hydroxy-cholesten-4 and estimate the probability that a participant had developed IC. The probability can range from 0 (no development of IC) to 1 (development of IC), with a higher number ind

Group	Value	95% CI
Alkaline phosphatase	0
Serum gamma glutamyl transferase	0
Total bile acid level	0
Fibroblast growth factor-19 level	0
7-alpha-hydroxy-cholesten-4 level	0

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.