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NCT04380311 · ClinicalTrials.gov registry record · NA
Precision Guided Tacrolimus Dosing in Pediatric Heart Transplant
A NA study of Heart Transplant Failure and Rejection, sponsored by University of Utah.
- Active
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 2
- Study locations
NCT04380311: Active NA study of Heart Transplant Failure and Rejection, sponsored by University of Utah.
NCT04380311 is a NA study of Heart Transplant Failure and Rejection that is active but no longer recruiting, run by University of Utah. The registered enrollment target is 15 participants, below the 208-participant average among 5 other Heart Transplant Failure and Rejection trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04380311, a NA study of Heart Transplant Failure and Rejection, is active but no longer recruiting, sponsored by University of Utah.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
Target attainment will be defined concentrations within the target range (10-14 ug/L) and no dose modifications for 3 consecutive days. Time to target concentration in the intervention arm will be compared to historical controls.
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 |
What the registry record for NCT04380311 still lists
NCT04380311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 208-participant average among 5 other Heart Transplant Failure and Rejection trials with a reported enrollment target (93% lower).
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.
NCT04380311 reports a single indexed study location in Utah.
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.
What interventions are being tested in trial NCT04380311?
The interventions under investigation include: Tacrolimus Dosing Support Tool (DEVICE).
Who is sponsoring clinical trial NCT04380311?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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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