Model-Informed Precision Dosing of Tacrolimus in Pediatric Kidney Transplantation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorHelwan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Non-adherent patients to tacrolimus.

Unavailable or missing data.

Trial population

Pediatric kidney recipients receiving tacrolimus

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
June 2026 - January 2027

Secondary outcomes

1

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.

Time frame
June 2026 - January 2027

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Helwan University

Lead sponsor

Cairo University

Collaborator

This trial is not recruiting at the moment. You can still explore other options: