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NCT06095895 Clinical Trial

Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment

Pharmacokinetics Clinical Trial

— MISSION  

Official title:
Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06095895
Other study ID # NL85390.091.23
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 15, 2023
Est. completion date February 15, 2025

Study information
Verified date October 2023
Source Radboud University Medical Center
Contact Astrid Heida, Msc
Phone +31 6 50026019
Email astrid.heida@radboudumc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date February 15, 2025
Est. primary completion date November 15, 2024
Accepts healthy volunteers No
Gender All
Age group 0 Years to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• venipuncture
An additional measurement of exposure of mycophenolic acid and/or tacrolimus will be performed

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Radboud University Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Bias Mean prediction error 1 year
Primary Precision Root mean squared error 1 year
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