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Not yet recruiting NCT07549230

Model-Informed Precision Dosing of Tacrolimus in Pediatric Kidney Transplantation

Conditions: Pediatric Kidney Transplantation

Sponsor: Helwan University

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations

Location information is not available.

Technical details
Status
Not yet recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Maximum age
18 Years
Healthy volunteers
No
Start date
01.06.2026
Completion date
01.06.2027
Registry ID
NCT07549230
Source
clinicaltrials.gov
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