Trial Outcomes & Findings for Precision Guided Tacrolimus Dosing in Pediatric Heart Transplant (NCT NCT04380311)
NCT ID: NCT04380311
Last Updated: 2026-08-03
Results Overview
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.
COMPLETED
NA
17 participants
Within 6 weeks following transplant
2026-08-03
Participant Flow
Participants were recruited to participate in the study within the first two days following transplant.
No significant events occurred between enrollment and assignment.
Participant milestones
| Measure |
Precision Tacrolimus
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.
Tacrolimus Dosing Support Tool: The tacrolimus dosing support tool is based on a population pharmacokinetic model that incorporates patient specific factors including age, renal function, and concomitant medications.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Precision Guided Tacrolimus Dosing in Pediatric Heart Transplant
Baseline characteristics by cohort
| Measure |
Personalized Tacrolimus Dosing
n=17 Participants
This arm will receive tacrolimus dosing based on population PK guided, individualized recommendations.
|
|---|---|
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Age, Continuous
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8 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Within 6 weeks following transplantPopulation: Two participants were removed from analysis - one for the inability to access the participant's chart in a timely manner and the second due to renal insufficiency that met the exclusion criteria and limited physician willingness to use the dosing recommendations.
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.
Outcome measures
| Measure |
Personalized Tacrolimus Dosing
n=15 Participants
This arm will receive tacrolimus dosing based on population PK guided, individualized recommendations.
|
|---|---|
|
Time to Target Concentration Attainment
|
6.93 days
Standard Deviation 3.59
|
Adverse Events
Personalized Tacrolimus Dosing
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place