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Immunosuppressant

Precision-Guided Tacrolimus Dosing for Heart Transplant Care

N/A

Waitlist Available

Led By Joseph E Rower, PhD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Received heart transplant for congenital heart malformation or cardiomyopathy

Age greater than 6 months and less than 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 6 weeks following transplant

Awards & highlights

Study Summary

This trial will help to improve long-term transplant survival outcomes by finding the best dose of immunosuppressant tacrolimus for each individual pediatric heart transplant patient.

Who is the study for?

This trial is for children and teens between the ages of 6 months to less than 18 years who have had a heart transplant due to congenital heart malformation or cardiomyopathy. Participants must be willing and able to follow study procedures, without significant other health issues that would interfere with completing the study.Check my eligibility

What is being tested?

The trial is testing a new precision medicine strategy for dosing tacrolimus, an immunosuppressant drug used to prevent organ rejection in pediatric heart transplant patients. The aim is to tailor medication doses more accurately for each child's unique body characteristics.See study design

What are the potential side effects?

While specific side effects are not listed here, tacrolimus can generally cause kidney problems, high blood pressure, tremors, and increased risk of infections. The precision dosing tool aims to minimize these by optimizing dosage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a heart transplant due to a birth defect or heart muscle disease.

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I am between 6 months and 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 6 weeks following transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 6 weeks following transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 weeks following transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to target concentration attainment

Trial Design

1Treatment groups

Experimental Treatment

Group I: Precision TacrolimusExperimental Treatment1 Intervention

Participants in this arm of the study will have their tacrolimus dose determined using a precision medicine decision support software tool. The participant's transplant physician will consider the recommended dose from the decision support tool in combination with the physician's expertise and experience to determine the proper tacrolimus dose for the participant.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor

1,098 Previous Clinical Trials

1,778,615 Total Patients Enrolled

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

3,834 Previous Clinical Trials

47,310,620 Total Patients Enrolled

Joseph E Rower, PhDPrincipal InvestigatorUniversity of Utah

Media Library

Tacrolimus (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT04380311 — N/A

Heart Transplant Rejection Research Study Groups: Precision Tacrolimus

Heart Transplant Rejection Clinical Trial 2023: Tacrolimus Highlights & Side Effects. Trial Name: NCT04380311 — N/A

Tacrolimus (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04380311 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there currently an opportunity for enrolment in this experiment?

"Yes, the information published on clinicaltrials.gov confirms that this investigation is actively seeking trial participants. Initially posted on May 1st 2020, and last updated on May 27th 2022, 16 subjects are being sought from two centres for enrolment in the study."

Answered by AI

Is this research study open to minors?

"To be eligible for this medical trial, potential participants must meet the age requirement of between 6 months and 18 years old. Additionally, two separate trials are being conducted to cater towards those under 18 while three additional ones will focus on patients above 65."

Answered by AI

Am I eligible to participate in the research study?

"This trial is searching for 16 people between the ages of 6 Months and 18 who are suffering from an underactive adrenal gland."

Answered by AI

How many participants are actively engaged in the clinical trial?

"Affirmative. As per the clinicaltrials.gov database, this research trial is currently seeking participants with an original posting date of May 1st 2020 and its latest update occurring on May 27th 2022. The study requires 16 individuals to be recruited from two separate sites."

Answered by AI

Recent research and studies

BMJ Paediatrics OpenJournal

Predicting Tacrolimus Concentrations in Children Receiving a Heart Transplant Using a Population Pharmacokinetic Model

Rower, Joseph E, Chris Stockmann, Matthew W Linakis, Shaun S Kumar, Xiaoxi Liu, E Kent Korgenski, Catherine M T Sherwin, and Kimberly M Molina. 2017. “Predicting Tacrolimus Concentrations in Children Receiving a Heart Transplant Using a Population Pharmacokinetic Model”. BMJ Paediatrics Open. BMJ. doi:10.1136/bmjpo-2017-000147.

clinicaltrials.govStudy

Precision Guided Tacrolimus Dosing in Pediatric Heart Transplant

Joseph Rower 2020. "Precision Guided Tacrolimus Dosing in Pediatric Heart Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04380311.