NCT06095895

Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 0 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pharmacokinetics
• Area Under Curve
• Tacrolimus
• Immunosuppressive Agents
• Mycophenolic Acid

Interventions

Type	Name	Description
OTHER	venipuncture	An additional measurement of exposure of mycophenolic acid and/or tacrolimus will be performed

Timeline

• Start date: 2024-03-15
• Primary completion: 2024-11-15
• Completion: 2025-11-20
• First posted: 2023-10-23
• Last updated: 2025-12-02

Locations

1 site across 1 country: Netherlands