Precision-Guided Tacrolimus Dosing for Heart Transplant Care

Recruiting at 1 trial location

Overseen By Joseph E Rower, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must be taking: Immunosuppressants

Disqualifiers: Significant comorbidity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

15 Participants Needed

Trial Summary

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.

Research Team

Joseph E Rower, PhD

Principal Investigator

University of Utah

Eligibility Criteria

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

I have had a heart transplant due to a birth defect or heart muscle disease.

Exclusion Criteria

Significant comorbidity that would prevent study completion

I am willing to follow all study procedures.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive precision-guided tacrolimus dosing to achieve target immunosuppression levels

6 weeks

Frequent visits for drug monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tacrolimus
• Tacrolimus Dosing Support Tool

Trial Overview The trial is testing a new precision medicine strategy for dosing tacrolimus, an immunosuppressant drug used to prevent organ rejection in pediatric heart transplant patients. The aim is to tailor medication doses more accurately for each child's unique body characteristics.

Participant Groups

Group I: Precision Tacrolimus Experimental Treatment 1 Intervention

Participants in this arm of the study will have their tacrolimus dose determined using a precision medicine decision support software tool. The participant's transplant physician will consider the recommended dose from the decision support tool in combination with the physician's expertise and experience to determine the proper tacrolimus dose for the participant.

Tacrolimus is already approved in European Union, United States, Canada, Japan, Switzerland for the following indications:

Approved in European Union as Prograf for:

• Prevention of organ rejection in liver, kidney, and heart transplant patients

Approved in United States as Prograf for:

• Prevention of organ rejection in liver, kidney, and heart transplant patients

Approved in Canada as Advagraf for:

• Prevention of organ rejection in liver, kidney, and heart transplant patients

Approved in Japan as Prograf for:

• Prevention of organ rejection in liver, kidney, and heart transplant patients

Approved in Switzerland as Prograf for:

• Prevention of organ rejection in liver, kidney, and heart transplant patients

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+