Model-Informed Precision Dosing of Tacrolimus in Pediatric Kidney Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pediatric Kidney Transplantation. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Model-Informed Precision Dosing of Tacrolimus in Pediatric Kidney Transplantation: A Hybrid Population Pharmacokinetics-Machine Learning Approach
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.
Primary outcome measures
- Development of a novel and applicable dosing algorithm. [Time frame: June 2026 - January 2027]
Secondary outcome measures (1)
- Reduction in the risk of acute graft rejection. [Time frame: June 2026 - January 2027]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07549230 · HU-FP-CP-2026-001