NCT03527238

Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Transplant
• Kidney Transplant

Interventions

Type	Name	Description
OTHER	PPM-based Computation Assisted Drug Dosing	Tacrolimus dosing based on application of PPM.
DRUG	Tacrolimus	Dosing of calcineurin inhibitor, tacrolimus

Timeline

• Start date: 2018-09-21
• Primary completion: 2020-06-02
• Completion: 2021-08-31
• First posted: 2018-05-17
• Last updated: 2021-12-10
• Results posted: 2021-12-10

Locations

3 sites across 2 countries: United States, Singapore

Regulatory

• FDA-regulated drug study