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Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment

NCT06095895 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2025-12-02

No results posted yet for this study

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

OTHER

venipuncture

An additional measurement of exposure of mycophenolic acid and/or tacrolimus will be performed

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Nynke Jager, Dr · Radboud University Medical Center

Eligibility

Min Age
0 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2024-11-15
Completion
2025-11-20

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06095895 on ClinicalTrials.gov