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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DK116140-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Clinical trial applying Phenotypic Precision Medicine (PPM) to tacrolimus dosing in liver and/or kidney transplant recipients to show improvement in maintaining drug trough levels within the target range.
The introduction of calcineurin inhibitors like tacrolimus has greatly reduced the incidence of acute rejection, improving graft and patient survival after transplantation. However, tacrolimus, one of the most widely used immunosuppressants and a mainstay of solid organ transplantation, has a narrow therapeutic index and wide pharmacokinetic variability. As such, there is a clear need for precision medicine to address post-transplant immunosuppression.
The study team has developed a powerful platform [Phenotypic Precision Medicine (PPM)] that utilizes patient-specific clinical data which represents each patient's response to drug treatment. This platform can efficiently prescribe precise and optimized drug doses despite the frequent changes to patient treatment regimens following transplantation. This potentially can have a profound effect on drug metabolism.
The aim of this project is to use PPM to uncover valuable and previously unknown information pertaining to patient dose requirements and correlate them with patient clinical and other contextual information. This study is also expected to reveal vital patient subpopulation information; and any future discovery of quantitative biomarkers as measures of immunosuppression will serve as a gateway towards even more effective personalized and relevant drug dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Standard of Care Tacrolimus Drug Dosing |
|
| Phenotypic Precision Medicine (PPM) | Experimental | PPM-based Computation Assisted Drug Dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PPM-based Computation Assisted Drug Dosing | Other | Tacrolimus dosing based on application of PPM. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tacrolimus Target Trough Level Maintenance | Percentage of Days Far (> 2 ng/mL) Out of Range of Tacrolimus Target Trough Level | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Zarrinpar, MD PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States | ||
| UF Health at the University of Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40379675 | Derived | Khong J, Lee M, Warren C, Kim UB, Duarte S, Andreoni KA, Shrestha S, Johnson MW, Battula NR, McKimmy DM, Beduschi T, Lee JH, Li DM, Ho CM, Zarrinpar A. Tacrolimus dosing in liver transplant recipients using phenotypic personalized medicine: A phase 2 randomized clinical trial. Nat Commun. 2025 May 16;16(1):4558. doi: 10.1038/s41467-025-59739-6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Standard of Care Tacrolimus Drug Dosing Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus |
| FG001 | Phenotypic Precision Medicine (PPM) | PPM-based Computation Assisted Drug Dosing PPM-based Computation Assisted Drug Dosing: Tacrolimus dosing based on application of PPM. Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | Standard of Care Tacrolimus Drug Dosing Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus |
| BG001 | Phenotypic Precision Medicine (PPM) | PPM-based Computation Assisted Drug Dosing PPM-based Computation Assisted Drug Dosing: Tacrolimus dosing based on application of PPM. Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Tacrolimus Target Trough Level Maintenance | Percentage of Days Far (> 2 ng/mL) Out of Range of Tacrolimus Target Trough Level | Posted | Mean | Standard Deviation | percentage of days | 2 weeks |
|
30 days after discharge
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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 | Standard of Care | Standard of Care Tacrolimus Drug Dosing Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rejection | Immune system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ali Zarrinpar | University of Florida | 352-265-0606 | ali.zarrinpar@surgery.ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 5, 2019 | Dec 8, 2021 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Tacrolimus | Drug | Dosing of calcineurin inhibitor, tacrolimus |
|
| Gainesville |
| Florida |
| 32610 |
| United States |
| National University of Singapore | Singapore | 119077 | Singapore |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 6 |
| 31 |
| EG001 | Phenotypic Precision Medicine (PPM) | PPM-based Computation Assisted Drug Dosing PPM-based Computation Assisted Drug Dosing: Tacrolimus dosing based on application of PPM. Tacrolimus: Dosing of calcineurin inhibitor, tacrolimus | 0 | 31 | 0 | 31 | 6 | 31 |
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