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Low Enrollment
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenofibrate | Drug | 160mg once daily orally for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of Fenofibrate | Proportion of subjects to discontinue fenofibrate due to adverse events | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Fenofibrate | Proportion of subjects with a new grade 3 or 4 adverse event | 12 weeks |
| Safety of Fenofibrate | Proportion of subjects with acute cellular rejection during fenofibrate treatment |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Channa Jayasekera, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85254 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tolerability of Fenofibrate | Proportion of subjects to discontinue fenofibrate due to adverse events | Posted | Count of Participants | Participants | 12 weeks |
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Adverse events were collected from the time of informed consent through study completion, approximately 16 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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Study was terminated early due to low enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Channa Jayasekera, M.D. | Mayo Clinic | 480-342-1095 | jayasekera.channa@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 28, 2022 | Jun 16, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| 12 weeks |
| 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 |
| Safety of Fenofibrate | Proportion of subjects myopathy confirmed by serum creatine kinase elevation | 16 weeks |
| Efficacy of Fenofibrate | Incidence of ischemic cholangiopathy in those treated with 12 weeks of fenofibrate, compared to a historical control group | 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. | 12 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Secondary | Safety of Fenofibrate | Proportion of subjects with a new grade 3 or 4 adverse event | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Safety of Fenofibrate | Proportion of subjects with acute cellular rejection during fenofibrate treatment | Posted | Count of Participants | Participants | 12 weeks |
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| Secondary | Safety of Fenofibrate | Mean change in calculated glomerular filtration rate before, during and after fenofibrate treatment | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | 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 | Posted | Count of Participants | Participants | 16 weeks |
|
|
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| Secondary | Efficacy of Fenofibrate | Incidence of ischemic cholangiopathy in those treated with 12 weeks of fenofibrate, compared to a historical control group | The historical cohort was not constructed due to inadequate enrollment of the treatment arm | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | 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. | No participant developed ischemic cholangiopathy, precluding analysis | Posted | Count of Participants | Participants | 12 weeks |
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |
| Title | Measurements |
|---|---|
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| Treatment Week 12 |
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| Post Treatment Week 4 |
|