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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 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.

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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.

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

FieldValue
Enrollment Target 15 participants
Start Date 2020-05-01
Est. Completion 2025-04-30
Phase NA

Sponsor

University of Utah

818 total trials

What the Registry Record Tells You About NCT04380311

The ClinicalTrials.gov registry entry for NCT04380311 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 208-participant average among 5 other Heart Transplant Failure and Rejection trials with a reported enrollment target (93% lower). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 1 distinct geographic area - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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