Trial Outcomes & Findings for A Study to Assess the Role of Fenofibrate in Preventing Ischemic Cholangiopathy After Liver Transplantation (NCT NCT05514119)

Results Overview

Proportion of subjects to discontinue fenofibrate due to adverse events

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-10-22

Participant Flow

Participant milestones

Participant milestones
Measure	Recipients of DCD liver transplants Subjects that underwent transplant of a liver donation after circulatory death (DCD) in the last 21-35 days received a 12 week fenofibrate (Lofibra) for a duration of 12 weeks Fenofibrate: 160mg once daily orally for 12 weeks
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Recipients of DCD liver transplants Subjects that underwent transplant of a liver donation after circulatory death (DCD) in the last 21-35 days received a 12 week fenofibrate (Lofibra) for a duration of 12 weeks Fenofibrate: 160mg once daily orally for 12 weeks
Overall Study Ineligible due to disease progression	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Recipients of DCD liver transplants n=6 Participants Subjects that underwent transplant of a liver donation after circulatory death (DCD) in the last 21-35 days received a 12 week fenofibrate (Lofibra) for a duration of 12 weeks Fenofibrate: 160mg once daily orally for 12 weeks
Age, Continuous	60.5 years STANDARD_DEVIATION 9.87 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Proportion of subjects to discontinue fenofibrate due to adverse events

Outcome measures

Outcome measures
Measure	Recipients of DCD liver transplants n=6 Participants Subjects that underwent transplant of a liver donation after circulatory death (DCD) in the last 21-35 days received a 12 week fenofibrate (Lofibra) for a duration of 12 weeks Fenofibrate: 160mg once daily orally for 12 weeks	Liver transplant patients not treated with fenofibrate (historical cohort) Subjects that underwent DCD liver transplantation between 1/1/2016-6/1/2021 and were not treated with fenofibrate	Total bile acid level Association between total bile acid level and development of ischemic cholangiopathy	Fibroblast growth factor-19 level Association between fibroblast growth factor-19 level and development of ischemic cholangiopathy	7-alpha-hydroxy-cholesten-4 level Association between 7-alpha-hydroxy-cholesten-4 level and development of ischemic cholangiopathy
Tolerability of Fenofibrate	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	Recipients of DCD liver transplants n=6 Participants Subjects that underwent transplant of a liver donation after circulatory death (DCD) in the last 21-35 days received a 12 week fenofibrate (Lofibra) for a duration of 12 weeks Fenofibrate: 160mg once daily orally for 12 weeks	Liver transplant patients not treated with fenofibrate (historical cohort) Subjects that underwent DCD liver transplantation between 1/1/2016-6/1/2021 and were not treated with fenofibrate	Total bile acid level Association between total bile acid level and development of ischemic cholangiopathy	Fibroblast growth factor-19 level Association between fibroblast growth factor-19 level and development of ischemic cholangiopathy	7-alpha-hydroxy-cholesten-4 level Association between 7-alpha-hydroxy-cholesten-4 level and development of ischemic cholangiopathy
Safety of Fenofibrate	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks

Proportion of subjects with acute cellular rejection during fenofibrate treatment

Outcome measures

Outcome measures
Measure	Recipients of DCD liver transplants n=6 Participants Subjects that underwent transplant of a liver donation after circulatory death (DCD) in the last 21-35 days received a 12 week fenofibrate (Lofibra) for a duration of 12 weeks Fenofibrate: 160mg once daily orally for 12 weeks	Liver transplant patients not treated with fenofibrate (historical cohort) Subjects that underwent DCD liver transplantation between 1/1/2016-6/1/2021 and were not treated with fenofibrate	Total bile acid level Association between total bile acid level and development of ischemic cholangiopathy	Fibroblast growth factor-19 level Association between fibroblast growth factor-19 level and development of ischemic cholangiopathy	7-alpha-hydroxy-cholesten-4 level Association between 7-alpha-hydroxy-cholesten-4 level and development of ischemic cholangiopathy
Safety of Fenofibrate	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Recipients of DCD liver transplants n=6 Participants Subjects that underwent transplant of a liver donation after circulatory death (DCD) in the last 21-35 days received a 12 week fenofibrate (Lofibra) for a duration of 12 weeks Fenofibrate: 160mg once daily orally for 12 weeks	Liver transplant patients not treated with fenofibrate (historical cohort) Subjects that underwent DCD liver transplantation between 1/1/2016-6/1/2021 and were not treated with fenofibrate	Total bile acid level Association between total bile acid level and development of ischemic cholangiopathy	Fibroblast growth factor-19 level Association between fibroblast growth factor-19 level and development of ischemic cholangiopathy	7-alpha-hydroxy-cholesten-4 level Association between 7-alpha-hydroxy-cholesten-4 level and development of ischemic cholangiopathy
Safety of Fenofibrate Baseline	75.3 mL/min/1.73m^2 Standard Deviation 13.0	—	—	—	—
Safety of Fenofibrate Treatment Week 4	62.7 mL/min/1.73m^2 Standard Deviation 24.2	—	—	—	—
Safety of Fenofibrate Treatment Week 8	62.2 mL/min/1.73m^2 Standard Deviation 26.5	—	—	—	—
Safety of Fenofibrate Treatment Week 12	51.4 mL/min/1.73m^2 Standard Deviation 21.7	—	—	—	—
Safety of Fenofibrate Post Treatment Week 4	60.5 mL/min/1.73m^2 Standard Deviation 19.6	—	—	—	—

SECONDARY outcome

Timeframe: 16 weeks

Proportion of subjects myopathy confirmed by serum creatine kinase elevation

Outcome measures

Outcome measures
Measure	Recipients of DCD liver transplants n=6 Participants Subjects that underwent transplant of a liver donation after circulatory death (DCD) in the last 21-35 days received a 12 week fenofibrate (Lofibra) for a duration of 12 weeks Fenofibrate: 160mg once daily orally for 12 weeks	Liver transplant patients not treated with fenofibrate (historical cohort) Subjects that underwent DCD liver transplantation between 1/1/2016-6/1/2021 and were not treated with fenofibrate	Total bile acid level Association between total bile acid level and development of ischemic cholangiopathy	Fibroblast growth factor-19 level Association between fibroblast growth factor-19 level and development of ischemic cholangiopathy	7-alpha-hydroxy-cholesten-4 level Association between 7-alpha-hydroxy-cholesten-4 level and development of ischemic cholangiopathy
Safety of Fenofibrate	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: The historical cohort was not constructed due to inadequate enrollment of the treatment arm

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

Outcome measures

Outcome measures
Measure	Recipients of DCD liver transplants n=6 Participants Subjects that underwent transplant of a liver donation after circulatory death (DCD) in the last 21-35 days received a 12 week fenofibrate (Lofibra) for a duration of 12 weeks Fenofibrate: 160mg once daily orally for 12 weeks	Liver transplant patients not treated with fenofibrate (historical cohort) Subjects that underwent DCD liver transplantation between 1/1/2016-6/1/2021 and were not treated with fenofibrate	Total bile acid level Association between total bile acid level and development of ischemic cholangiopathy	Fibroblast growth factor-19 level Association between fibroblast growth factor-19 level and development of ischemic cholangiopathy	7-alpha-hydroxy-cholesten-4 level Association between 7-alpha-hydroxy-cholesten-4 level and development of ischemic cholangiopathy
Efficacy of Fenofibrate	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks

Population: No participant developed ischemic cholangiopathy, precluding analysis

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 indicating a worse outcome.

Outcome measures

Outcome measures
Measure	Recipients of DCD liver transplants n=6 Participants Subjects that underwent transplant of a liver donation after circulatory death (DCD) in the last 21-35 days received a 12 week fenofibrate (Lofibra) for a duration of 12 weeks Fenofibrate: 160mg once daily orally for 12 weeks	Liver transplant patients not treated with fenofibrate (historical cohort) n=6 Participants Subjects that underwent DCD liver transplantation between 1/1/2016-6/1/2021 and were not treated with fenofibrate	Total bile acid level n=6 Participants Association between total bile acid level and development of ischemic cholangiopathy	Fibroblast growth factor-19 level n=6 Participants Association between fibroblast growth factor-19 level and development of ischemic cholangiopathy	7-alpha-hydroxy-cholesten-4 level n=6 Participants Association between 7-alpha-hydroxy-cholesten-4 level and development of ischemic cholangiopathy
The Number of Participants Who Developed Ischemic Cholangiopathy (IC)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Recipients of DCD liver transplants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Channa Jayasekera, M.D.

Mayo Clinic

Phone: 480-342-1095

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place