Liver TransplantPhase 2FICsDCDNCT05514119
A Study to Assess the Role of Fenofibrate in Preventing Ischemic Cholangiopathy After Liver Transplantation
A Phase 2 study testing Fenofibrate in people with Liver Transplant, run by Mayo Clinic at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant
- What is being tested?
- Fenofibrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2022to 1 Dec 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
- Adults lacking capacity to consent to treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fenofibrate to Prevent Ischemic Cholangiopathy in Donation After Circulatory Death Liver Transplantation (FICsDCD)
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).
Read the 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.
- Conditions
- Liver Transplant
- Being tested
- Fenofibrate
- Keywords
- Ischemic Cholangiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenofibrateDrug
Also called Lofibra
160mg once daily orally for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Recipients of DCD liver transplants | Experimental | 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 Receives: Drug: Fenofibrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of Fenofibrate
Proportion of subjects to discontinue fenofibrate due to adverse events
Measured: 12 weeks
Secondary outcomes (6)
Safety of Fenofibrate
Proportion of subjects with a new grade 3 or 4 adverse event
Measured: 12 weeks
Safety of Fenofibrate
Proportion of subjects with acute cellular rejection during fenofibrate treatment
Measured: 12 weeks
Safety of Fenofibrate
Mean change in calculated glomerular filtration rate before, during and after fenofibrate treatment
Measured: Baseline, treatment weeks 4, 8, 12, and at 4 weeks after end of treatment
Safety of Fenofibrate
Proportion of subjects myopathy confirmed by serum creatine kinase elevation
Measured: 16 weeks
Efficacy of Fenofibrate
Incidence of ischemic cholangiopathy in those treated with 12 weeks of fenofibrate, compared to a historical control group
Measured: 12 weeks
The Number of Participants Who Developed Ischemic Cholangiopathy (IC)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start17 Aug 2022
- Primary completion30 Jun 2024
- Study completion1 Dec 2024
Why it stopped: Low Enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Channa R Jayasekera, MD, MSc, Mayo Clinic
- Investigators
- Channa Jayasekera, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05514119
- Sponsor's protocol ID
- 22-007122
- Acronym
- FICsDCD
- Status last verified
- Sep 2025
- First submitted
- 23 Aug 2022
- Last updated
- 22 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fenofibrate to Prevent Ischemic Cholangiopathy in Donation After Circulatory Death Liver Transplantation (FICsDCD)
- ClinicalTrials.gov ID
- NCT05514119
- Acronym / sponsor ID
- FICsDCD / 22-007122
- Conditions
- Liver Transplant
- Keywords
- Ischemic Cholangiography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 24 Aug 2022 (actual)
- Results
- Posted 22 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recipients of DCD liver transplants | Experimental | Drug: FenofibrateSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FenofibrateAlso: Lofibra160mg once daily orally for 12 weeks | Drug | Recipients of DCD liver transplants |
Primary outcome
Tolerability of Fenofibrate
Time frame: 12 weeks
Proportion of subjects to discontinue fenofibrate due to adverse events
6 secondary outcomes
Safety of Fenofibrate
Time frame: 12 weeks
Safety of Fenofibrate
Time frame: 12 weeks
Safety of Fenofibrate
Time frame: Baseline, treatment weeks 4, 8, 12, and at 4 weeks after end of treatment
Safety of Fenofibrate
Time frame: 16 weeks
Efficacy of Fenofibrate
Time frame: 12 weeks
The Number of Participants Who Developed Ischemic Cholangiopathy (IC)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Channa Jayasekera, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fenofibrate in people with Liver Transplant, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability of Fenofibrate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.