Model-Informed Precision Dosing of Tacrolimus in Pediatric Kidney Transplantation

Helwan University

Status: Not yet enrolling

Conditions: Pediatric Kidney Transplantation

Study type: Observational

Funder types: Other

Identifiers

NCT07549230

HU-FP-CP-2026-001

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.