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Completed NCT04380311

Precision Guided Tacrolimus Dosing in Pediatric Heart Transplant

Conditions: Heart Transplant Failure and Rejection

Sex: All
Ages: 6 Months – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 17
Sponsor: University of Utah

Location: Primary Children's Hospital Salt Lake City Utah

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.

Eligibility Criteria

Inclusion Criteria: 1. Age greater than 6 months and less than 18 years. 2. Received heart transplant for congenital heart malformation or cardiomyopathy. Exclusion Criteria: 1. Unwillingness to complete study procedures. 2. Significant comorbidity that would prevent study completion.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04380311). StuddyBuddy aggregates publicly available trial information.