Precision Guided Tacrolimus Dosing in Pediatric Heart Transplant

Completed · Not applicable

Conditions studied: Heart Transplant Failure and Rejection

In brief

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.

Key facts

Study ID

NCT04380311

Run by

University of Utah

People needed

17

Starts

2020-05-01

Expected to finish

2025-04-30

Last updated by the study team

2026-08-03

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than 6 months and less than 18 years.
• Received heart transplant for congenital heart malformation or cardiomyopathy.

You may not qualify if…

• Unwillingness to complete study procedures.
• Significant comorbidity that would prevent study completion.

Where it is running

• Primary Children's Hospital — Salt Lake City, Utah, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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