Precision Guided Tacrolimus Dosing in Pediatric Heart Transplant

NCT04380311 | Active Not Recruiting FDA Device

• 2 other identifiers: IRB_00124800K01HL148402
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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

Heart Transplant Failure and Rejection

Keywords

Tacrolimus, Pediatrics

Outcome Measures

Primary Outcomes (1)

• Time to target concentration attainment

  Target attainment will be defined concentrations within the target range (10-15 ug/L) and no dose modifications for 3 consecutive days. Time to target concentration in the intervention arm will be compared to historical controls.

  Within 6 weeks following transplant

Study Arms (1)

Precision Tacrolimus

EXPERIMENTAL

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.

Device: Tacrolimus Dosing Support Tool

Interventions

Tacrolimus Dosing Support Tool DEVICE

The tacrolimus dosing support tool is based on a population pharmacokinetic model that incorporates patient specific factors including age, renal function, and concomitant medications.

Also known as: Tacrolimus

Precision Tacrolimus

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age greater than 6 months and less than 18 years.
• Received heart transplant for congenital heart malformation or cardiomyopathy.

You may not qualify if:

• Unwillingness to complete study procedures.
• Significant comorbidity that would prevent study completion.

Sponsors & Collaborators

• University of Utah: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Primary Children's Hospital

Salt Lake City, Utah, 84112, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• Rower JE, Stockmann C, Linakis MW, Kumar SS, Liu X, Korgenski EK, Sherwin CMT, Molina KM. Predicting tacrolimus concentrations in children receiving a heart transplant using a population pharmacokinetic model. BMJ Paediatr Open. 2017;1(1):e000147. doi: 10.1136/bmjpo-2017-000147. Epub 2017 Nov 22.

  PMID: 29177199 BACKGROUND

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Joseph E Rower, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 8, 2020
• Study Start: May 1, 2020
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)