Model-Informed Precision Dosing of Tacrolimus in Pediatric Kidney Transplantation (NCT07549230)
Summary
This ClinicalTrials.gov entry registers an observational study (NCT07549230) investigating model-informed precision dosing of tacrolimus in pediatric kidney transplantation. The study aims to develop a clinical decision support tool using hybrid population pharmacokinetics and machine learning to individualize tacrolimus dosing and reduce acute graft rejection risk. No regulatory obligations or compliance deadlines are created by this study registration.
“The purpose of this study is to develop a novel and applicable dosing algorithm that helps support the clinical decision to achieve tacrolimus levels within the optimal immunosuppression range despite sparse sampling in routine clinical practice in pediatric kidney transplantation.”
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What changed
This ClinicalTrials.gov study registration documents a new observational study (NCT07549230) titled 'Model-Informed Precision Dosing of Tacrolimus in Pediatric Kidney Transplantation.' The study will develop a clinical decision support tool (CDST) combining population pharmacokinetics with machine learning for tacrolimus dose individualization in pediatric kidney transplant recipients. The study addresses sparse sampling challenges in routine clinical practice.
Healthcare providers involved in pediatric kidney transplantation and clinical researchers in transplant pharmacology should note this study's focus on developing algorithmic dose optimization. Pharmaceutical manufacturers of immunosuppressants may find relevance in the dosing algorithm research. No immediate compliance obligations arise from this study registration.
Archived snapshot
Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Model-Informed Precision Dosing of Tacrolimus in Pediatric Kidney Transplantation
Observational NCT07549230 Kind: OBSERVATIONAL Apr 24, 2026
Abstract
The purpose of this study is to develop a novel and applicable dosing algorithm that helps support the clinical decision to achieve tacrolimus levels within the optimal immunosuppression range despite sparse sampling in routine clinical practice in pediatric kidney transplantation. This clinical decision support tool (CDST) is based on a hybrid population pharmacokinetics-machine learning approach aiming for tacrolimus dose individualization and reducing the risk of acute graft rejection.
Conditions: Pediatric Kidney Transplantation
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