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Heart Transplant Failure and Rejection / Tacrolimus Dosing Support Tool · Interventional Study
ClinicalTrials.gov · August 3, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed registry record for a single-arm interventional study of a tacrolimus dosing support tool in 17 pediatric heart transplant recipients. No efficacy, safety, or outcome data are reported in this registry record; results must be obtained from peer-reviewed publication or updated registry posting to evaluate clinical utility.
Interventional, Single Group, Open label, Treatment purpose. Heart Transplant Failure and Rejection; age from 6 Months; to 18 Years. Intervention: Precision Tacrolimus. n = 17. 2 sites: United States.
This is a completed registry record for a single-arm interventional study of a tacrolimus dosing support tool in 17 pediatric heart transplant recipients. No efficacy, safety, or outcome data are reported in this registry record; results must be obtained from peer-reviewed publication or updated registry posting to evaluate clinical utility.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
Clinicians and researchers should await publication of efficacy and safety results before incorporating this dosing tool into practice. The potential to improve tacrolimus therapeutic drug monitoring and long-term transplant survival in children warrants completion of this research.
Completed registry study of a precision dosing device in 17 pediatric heart transplant recipients; no results posted, so efficacy and safety remain unreported.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians and researchers should await publication of efficacy and safety results before incorporating this dosing tool into practice. The potential to improve tacrolimus therapeutic drug monitoring and long-term transplant survival in children warrants completion of this research.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04380311). This is a study registration, not published results. Lead sponsor: University of Utah. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 17 participants (ACTUAL). Conditions: Heart Transplant Failure and Rejection. Interventions: DEVICE: Tacrolimus Dosing Support Tool. Primary outcome measures: Time to Target Concentration Attainment , Within 6 weeks following transplant. 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.