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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Kidney Transplantation

• Study Type: Observational
• Enrollment (Estimated): 130

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Pediatric kidney recipients receiving tacrolimus

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in the risk of acute graft rejection.	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.	June 2026 - January 2027

Collaborators and Investigators

• Sponsor: Helwan University
• Collaborators: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 18, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HU-FP-CP-2026-001