Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment
- Conditions
- Area Under CurveMycophenolic AcidPharmacokineticsTacrolimusImmunosuppressive Agents
- Registration Number
- NCT06095895
- Lead Sponsor
- Radboud University Medical Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Kidney transplant patients using tacrolimus and/or mycophenolic acid
- Age between 0 and 18 years
- Indication for an AUC measurement - judgement of clinician
- Incapacitated patients
- No informed consent
- Not proficient in the Dutch language
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bias 1 year Mean prediction error
Precision 1 year Root mean squared error
- Secondary Outcome Measures
Name Time Method