Area Under Curve, Immunosuppressive Agents, Mycophenolic Acid, Pharmacokinetics, Tacrolimus
Conditions
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.
Interventions
OTHERvenipuncture
An additional measurement of exposure of mycophenolic acid and/or tacrolimus will be performed
Sponsors
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bias | 1 year | Mean prediction error |
| Precision | 1 year | Root mean squared error |
Countries
Netherlands
Outcome results
None listed