Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Details

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.

Keywords

Liver Transplant Kidney Transplant Phenotypic Precision Medicine (PPM) Tacrolimus Calcineurin Inhibitors PPM-based Computation Assisted Drug Dosing

Eligibility

You can join if…

Open to people ages 18-99

  • adults undergoing liver and/or kidney transplantation

You CAN'T join if...

  • transplant patients with contraindications to tacrolimus

Locations

  • UCLA
    Los Angeles California 90095 United States
  • UF Health at the University of Florida
    Gainesville Florida 32610 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Florida
ID
NCT03527238
Phase
Phase 2
Study Type
Interventional
Last Updated