Model-Informed Precision Dosing of Tacrolimus in Pediatric Kidney Transplantation

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07549230

Enrollment

130

Registered

2026-04-24

Start date

2026-06-01

Completion date

2027-06-01

Last updated

2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Kidney Transplantation

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Development of a novel and applicable dosing algorithm.	June 2026 - January 2027	A dosing algorithm that rapidly achieves accurate tacrolimus levels within the optimal immunosuppression range despite sparse sampling in routine clinical practice.

Secondary

Measure	Time frame	Description
Reduction in the risk of acute graft rejection.	June 2026 - January 2027	Reduction in the risk of acute graft rejection by developing a clinical decision support tool (CDST) to guide the dose individualization of tacrolimus following pediatric kidney transplantation.

Outcome results