Status:
ACTIVE_NOT_RECRUITING
Precision Guided Tacrolimus Dosing in Pediatric Heart Transplant
Lead Sponsor:
University of Utah
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Heart Transplant Failure and Rejection
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief 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 elimina...
Detailed Description
Of the more than 400 children annually receiving a heart transplant, the likelihood that the child dies within five years (25%) is equivalent to the potential that the child lives \>20 years post-tran...
Eligibility Criteria
Inclusion
- Age greater than 6 months and less than 18 years.
- Received heart transplant for congenital heart malformation or cardiomyopathy.
Exclusion
- Unwillingness to complete study procedures.
- Significant comorbidity that would prevent study completion.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04380311
Start Date
May 1 2020
End Date
April 30 2025
Last Update
January 7 2025
Active Locations (2)
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1
Primary Children's Hospital
Salt Lake City, Utah, United States, 84112
2
University of Utah
Salt Lake City, Utah, United States, 84112