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Can a smart dosing tool prevent heart transplant rejection in children?

NCT ID NCT04380311

Disease control Sponsor: University of Utah Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This study tests a personalized dosing tool for tacrolimus, an immunosuppressant drug given to children after a heart transplant to prevent organ rejection. The tool uses a computer model that considers each child's age, kidney function, and other medications to calculate the best dose. The goal is to see if this approach helps children reach the target drug level faster and more consistently than standard dosing, which could improve long-term transplant outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tacrolimus dosing support tool (a computer model that personalizes tacrolimus doses based on patient factors)
What this could lead to
If successful, this could lead to a more precise way to dose tacrolimus in children after heart transplant, potentially reducing rejection and improving long-term transplant survival.
What could go wrong
This is a small study (17 participants) and compares against historical data, so results may not be definitive. The tool's accuracy depends on the model's assumptions and may not work for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

17 people

The number who actually took part.

Started

May 2020

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age greater than 6 months and less than 18 years. 2. Received heart transplant for congenital heart malformation or cardiomyopathy. Exclusion Criteria: 1. Unwillingness to complete study procedures. 2. Significant comorbidity that would prevent study completion.

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Conditions

The condition(s) this trial relates to.

Rejection, Psychology transplant rejection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart transplant failure and rejection

Contacts and locations

Locations

  • Primary Children's Hospital

    Salt Lake City, Utah, 84112, United States

  • University of Utah

    Salt Lake City, Utah, 84112, United States

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