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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| venipuncture | Other | An additional measurement of exposure of mycophenolic acid and/or tacrolimus will be performed |
| Measure | Description | Time Frame |
|---|---|---|
| Bias | Mean prediction error | 1 year |
| Precision | Root mean squared error | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Paediatric kidney transplant patients from Radboudumc using tacrolimus and/or mycophenolic acid.
We will collect data for one year, in this period we expect to include 30 patients.
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| Name | Affiliation | Role |
|---|---|---|
| Nynke Jager, Dr | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Nijmegen | Gelderland | 6500HB | Netherlands |
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| ID | Term |
|---|---|
| D018962 | Phlebotomy |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| D003933 | Diagnosis |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |