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Precision Guided Tacrolimus Dosing in Pediatric Heart Transplant

NCT04380311 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-01-07

No results posted yet for this study

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.

Conditions

  • Heart Transplant Failure and Rejection

Interventions

DEVICE

Tacrolimus Dosing Support Tool

The tacrolimus dosing support tool is based on a population pharmacokinetic model that incorporates patient specific factors including age, renal function, and concomitant medications.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of Utah

    lead OTHER

Principal Investigators

  • Joseph E Rower, PhD · University of Utah

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2025-04-30
Completion
2025-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04380311 on ClinicalTrials.gov