Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-15

Study Completion Date

2025-11-20

Brief Summary

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This is a prospective observational study of MIPD in clinical practice for paediatric kidney transplant patients using tacrolimus and mycophenolic acid in Radboudumc. Dose individualization in paediatric kidney transplant patients using the InsightRX platform is performed as standard care, meaning that a pharmacokinetic model and drug levels measured at t=0, t=1 and t=2 hours will be used to calculate the exposure. Based on the estimated exposure, the pharmacist gives a dose recommendation to the physician, who can then modify the dosage of mycophenolic acid or tacrolimus. The selected dose and the measured MPA and tacrolimus concentrations will be used to predict the future exposure. A second exposure measurement will be performed to evaluate whether our model is able to predict future exposure.

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Detailed Description

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Conditions

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Pharmacokinetics Area Under Curve Tacrolimus Immunosuppressive Agents Mycophenolic Acid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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venipuncture

An additional measurement of exposure of mycophenolic acid and/or tacrolimus will be performed

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Kidney transplant patients using tacrolimus and/or mycophenolic acid
* Age between 0 and 18 years
* Indication for an AUC measurement - judgement of clinician