Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine

Kidney Transplant Clinical Trial

— PPM - Pro  

Official title:

Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03527238
• Other study ID #: IRB201800053 -N -A
• Secondary ID: 1R21DK116140-01
• Status: Completed
• Phase: Phase 2
• Start date: September 21, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: December 2021
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 31, 2021
• Est. primary completion date: June 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• adults undergoing liver and/or kidney transplantation

Exclusion Criteria:

• transplant patients with contraindications to tacrolimus

Related Conditions & MeSH terms

• Kidney Transplant
• Liver Transplant

Intervention

Other:
• PPM-based Computation Assisted Drug Dosing
Tacrolimus dosing based on application of PPM.

Drug:
• Tacrolimus
Dosing of calcineurin inhibitor, tacrolimus

Locations

Country	Name	City	State
Singapore	National University of Singapore	Singapore
United States	UF Health at the University of Florida	Gainesville	Florida
United States	UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Countries where clinical trial is conducted

United States,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tacrolimus Target Trough Level Maintenance	Percentage of Days Far (> 2 ng/mL) Out of Range of Tacrolimus Target Trough Level	2 weeks