Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment

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.

Completed

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Key information

Conditions

Pharmacokinetics Area Under Curve Immunosuppressive Agents Mycophenolic Acid Tacrolimus

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Radboudumc

Nijmegen, Gelderland, 6500HB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

Incapacitated patients
No informed consent
Not proficient in the Dutch language

Treatment and study plan

Venipuncture

Other

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

Primary outcomes

Bias

Time frame: 1 year

Mean prediction error
Precision

Time frame: 1 year

Root mean squared error

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Acronym: MISSION

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: Oct 23, 2023
Registry last updated: Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed