Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine

Phase 2

Completed

• Conditions: Liver Transplant; Kidney Transplant
• Interventions: Other: PPM-based Computation Assisted Drug Dosing; Drug: Tacrolimus

• Registration Number: NCT03527238
• Lead Sponsor: University of Florida

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-05-04
• Study First Submitted QC: 2018-05-04
• Study First Posted: 2018-05-17
• Study Start: 2018-09-21
• Primary Completion: 2020-06-02
• Study Completion: 2021-08-31
• Results First Submitted: 2021-11-12
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-09
• Last Update Submitted: 2021-12-09
• Results First Posted: 2021-12-10
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• adults undergoing liver and/or kidney transplantation

Exclusion Criteria

• transplant patients with contraindications to tacrolimus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phenotypic Precision Medicine (PPM)	PPM-based Computation Assisted Drug Dosing	PPM-based Computation Assisted Drug Dosing
Standard of Care	Tacrolimus	Standard of Care Tacrolimus Drug Dosing
Phenotypic Precision Medicine (PPM)	Tacrolimus	PPM-based Computation Assisted Drug Dosing

Primary Outcome Measures

Name	Time	Method
Tacrolimus Target Trough Level Maintenance	2 weeks	Percentage of Days Far (\> 2 ng/mL) Out of Range of Tacrolimus Target Trough Level

Trial Locations

Locations (3)

UCLA; 🇺🇸 Los Angeles, California, United States

National University of Singapore; 🇸🇬 Singapore, Singapore

UF Health at the University of Florida; 🇺🇸 Gainesville, Florida, United States