Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine

Conditions
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Liver Transplant, Kidney Transplant

Intervention / Treatment
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* Other: PPM-based Computation Assisted Drug Dosing
* Drug: Tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults undergoing liver and/or kidney transplantation Exclusion Criteria: transplant patients with contraindications to tacrolimus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>Standard of Care Tacrolimus Drug Dosing | Drug: Tacrolimus<br>* Dosing of calcineurin inhibitor, tacrolimus<br>|
| Experimental: Phenotypic Precision Medicine (PPM)<br>PPM-based Computation Assisted Drug Dosing | Other: PPM-based Computation Assisted Drug Dosing<br>* Tacrolimus dosing based on application of PPM.<br>* Other names: Computation based dosing;Drug: Tacrolimus<br>* Dosing of calcineurin inhibitor, tacrolimus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phenotypic Precision Medicine (PPM), Tacrolimus, Calcineurin Inhibitors