Precision-Guided Tacrolimus Dosing for Heart Transplant Care
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Joseph E Rower, PhD
Principal Investigator
University of Utah
Are You a Good Fit for This Trial?
This trial is for children and teens between the ages of 6 months to less than 18 years who have had a heart transplant due to congenital heart malformation or cardiomyopathy. Participants must be willing and able to follow study procedures, without significant other health issues that would interfere with completing the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive precision-guided tacrolimus dosing to achieve target immunosuppression levels
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tacrolimus
- Tacrolimus Dosing Support Tool
Tacrolimus is already approved in European Union, United States, Canada, Japan, Switzerland for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Utah
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator