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ACTIVE NOT RECRUITING
NCT04380311
NA

Precision Guided Tacrolimus Dosing in Pediatric Heart Transplant

Sponsor: University of Utah

View on ClinicalTrials.gov

Summary

Immunosuppressive therapy is required to prevent organ rejection, however, dosing of immunosuppressive agents is complicated by patient-specific differences impacting the body's absorption and elimination of these agents. The goal of this research proposal is to clinically validate an innovative precision medicine strategy for dosing the immunosuppressant tacrolimus in pediatric heart transplant, which will in turn lead to improvements in long-term transplant survival outcomes. The strategy and techniques used in this project can be extended to improve drug therapy across multiple pediatric diseases requiring chronic therapy.

Official title: Precision Pharmacokinetic-Guided Tacrolimus Dosing to Improve Pediatric Heart Transplant Outcomes

Key Details

Gender

All

Age Range

6 Months - 18 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2020-05-01

Completion Date

2025-04-30

Last Updated

2025-01-07

Healthy Volunteers

No

Interventions

DEVICE

Tacrolimus Dosing Support Tool

The tacrolimus dosing support tool is based on a population pharmacokinetic model that incorporates patient specific factors including age, renal function, and concomitant medications.

Locations (2)

Primary Children's Hospital

Salt Lake City, Utah, United States

University of Utah

Salt Lake City, Utah, United States