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Precision Guided Tacrolimus Dosing in Pediatric Heart Transplant
NCT04380311 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DEVICE Tacrolimus Dosing Support Tool
Study Locations (2)
Utah
- Primary Children's Hospital — Salt Lake City
- University of Utah — Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2020-05-01 |
| Est. Completion | 2025-04-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04380311
The ClinicalTrials.gov registry entry for NCT04380311 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 686 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Heart Transplant Failure and Rejection appearing as the primary indexed condition, and to 1 intervention — of which Tacrolimus Dosing Support Tool is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04380311 reports 2 study locations spanning 1 distinct geographic area — top geographies include Utah. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04380311 about?
NCT04380311 is a clinical study titled "Precision Guided Tacrolimus Dosing in Pediatric Heart Transplant". 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 pre...
What is the current status of trial NCT04380311?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2020-05-01. Estimated completion is 2025-04-30.
What conditions does trial NCT04380311 study?
This clinical trial studies the following conditions: Heart Transplant Failure and Rejection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04380311?
The interventions under investigation include: Tacrolimus Dosing Support Tool (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04380311?
This trial is sponsored by University of Utah, which has 686 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04380311 being conducted?
This trial has 2 study locations across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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