Model Informed preciSion doSIng tO iNdividualise and optimize pharmacotherapeutic treatment (MISSION) - Appendix 1: Prospective evaluation of Model informed precision dosing (MIPD) for tacrolimus and mycophenolic acid in paediatric patients with a kidney disease

Model Informed preciSion doSIng tO iNdividualise and optimize pharmacotherapeutic treatment (MISSION) - Appendix 1: Prospective evaluation of Model informed precision dosing (MIPD) for tacrolimus and mycophenolic acid in paediatric patients with a kidney disease - MISSION

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56572

Enrollment

Registered

2023-10-02

Start date

2024-05-14

Completion date

Unknown

Last updated

2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

kidney diseases

Interventions

&nbsp

Overall objective:To improve the existing drug prescribing and treatment monitoring process. Objective appendix 1: To prospectively evaluate the predictive performance of the MIPD strategy for tacroli

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria:  -Kidney disease patients using tacrolimus and/or mycophenolic acid  -Age between 0 and 18 yearse- judgement of clinician 

Exclusion criteria

Exclusion criteria:  - Incapacitated patients - No informed consent 

Design outcomes

Primary

Measure	Time frame
Appendix 1: • The bias and precision calculated as Mean Prediction Error (MPE) and Root Mean Squared Percentage Error (RMSE) and written in their relative values for easy interpretation (%MPE and %RMSE). • 95 percent confidence intervals (95% CI*s) of the MPE and the RMSE • Target attainment calculated as the percentage of cases in which the subsequent AUC lies within the target range. • Model fit calculated as percentage of poor, intermediate and good fit.	—

Measure

Time frame

Appendix 1: • The bias and precision calculated as Mean Prediction Error (MPE) and Root Mean Squared Percentage Error (RMSE) and written in their relative values for easy interpretation (%MPE and %RMSE). • 95 percent confidence intervals (95% CI*s) of the MPE and the RMSE • Target attainment calculated as the percentage of cases in which the subsequent AUC lies within the target range. • Model fit calculated as percentage of poor, intermediate and good fit.

—

Secondary

Measure	Time frame
Appendix 1: NA	—

Countries

Netherlands

Contacts

Public ContactA Heida

Radboud Universitair Medisch Centrum

astrid.heida@radboudumc.nl(024) 361 11 11

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)