Not_yet_recruitingNCT07549230

Model-Informed Precision Dosing of Tacrolimus in Pediatric Kidney Transplantation: A Hybrid Population Pharmacokinetics-Machine Learning Approach

Sponsor: Helwan University

Trial Details

Condition	Pediatric Kidney Transplantation
Status	Not_yet_recruiting
Participants	130
Est. Completion	1 Jan 2027
Last Updated	29 Apr 2026

Primary Outcome

Development of a novel and applicable dosing algorithm.

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: * Pediatric patients (\< 18 years old). * First-time kidney transplant recipients who have less than 20% PRA and no DSA. * Adherent to tacrolimus for a year post-transplantation. * All data, including therapeutic drug monitoring (TDM) data, are available. Exclusion Criteria: * Non-adherent patients to tacrolimus. * Unavailable or missing data.

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Related Analysis

Novel Tacrolimus Dosing Algorithm Trial Opens for Paediatric Kidney Transplant Recipients — Precision Medicine Approach to Prevent Rejection

New research aims to develop a precision dosing algorithm for tacrolimus in paediatric kidney transplant recipients, potentially improving graft outcomes while reducing monitoring burden. The study combines population pharmacokinetics with computational methods to individualise immunosuppressive therapy.

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