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NCT04380311Completed

Precision Guided Tacrolimus Dosing in Pediatric Heart Transplant

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

Source: ClinicalTrials.gov · Last updated 3 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
17 (actual)
First submitted
5 May 2020
Start date
1 May 2020
Primary completion date
30 Apr 2025
Lead sponsor
University of Utah
NCT number
NCT04380311

What you commit to

  • Study type: Interventional
  • Participants enrolled: 17
  • From 1 May 2020 to the primary completion date, 30 Apr 2025
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

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

Who the study is looking for

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

Age in the registry: 6 months to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Primary Children's Hospital
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesUnknown status
University of Utah
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.