Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine (PPM - Pro)

University of Florida

Status and phase: Completed; Phase 2

Conditions: Kidney Transplant; Liver Transplant

Treatments: Drug: Tacrolimus; Other: PPM-based Computation Assisted Drug Dosing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03527238

IRB201800053 -N -A

1R21DK116140-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adults undergoing liver and/or kidney transplantation

Exclusion criteria

• transplant patients with contraindications to tacrolimus

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

Standard of Care Tacrolimus Drug Dosing

Treatment:

Drug: Tacrolimus

Phenotypic Precision Medicine (PPM)

Experimental group

Description:

PPM-based Computation Assisted Drug Dosing

Treatment:

Other: PPM-based Computation Assisted Drug Dosing

Drug: Tacrolimus