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Completed

NCT Number: NCT03527238

Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine

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.

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Key information

Conditions

Liver Transplant Kidney Transplant

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National University of Singapore, Singapore

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults undergoing liver and/or kidney transplantation

Exclusion criteria

  • transplant patients with contraindications to tacrolimus

Treatment and study plan

PPM-based Computation Assisted Drug Dosing

Other

Tacrolimus dosing based on application of PPM.

Other names: Computation based dosing

Tacrolimus

Drug

Dosing of calcineurin inhibitor, tacrolimus

Primary outcomes

  1. Tacrolimus Target Trough Level Maintenance

    Time frame: 2 weeks

    Percentage of Days Far (> 2 ng/mL) Out of Range of Tacrolimus Target Trough Level

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: PPM - Pro

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
May 17, 2018
Registry last updated
Dec 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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