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Search / Trial NCT06095895

Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Oct 16, 2023

Trial Information

Current as of July 01, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to personalize the medication doses for children who have received a kidney transplant. The focus is on two specific medications, tacrolimus and mycophenolic acid, which help prevent the body from rejecting the new kidney. Researchers at Radboudumc will use a special tool called the InsightRX platform to analyze the levels of these medications in the blood. By measuring how much of the drug is in the body at different times, the pharmacist can recommend the best dose for each patient. The goal is to ensure that each child receives the right amount of medication to keep them healthy.

To be eligible for this study, participants must be between 0 and 18 years old and currently taking tacrolimus and/or mycophenolic acid after a kidney transplant. It's important that they have a reason for the dose measurement as decided by their doctor. Children who are unable to understand the study or cannot give consent, as well as those who do not speak Dutch, cannot participate. This trial is not yet recruiting participants, but it aims to improve future treatment by making sure the right dosage is given based on individual needs.

Gender

ALL

Eligibility criteria

  • 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

About Radboud University Medical Center

Radboud University Medical Center is a leading academic medical institution located in Nijmegen, the Netherlands, dedicated to advancing healthcare through innovative research and education. As a prominent sponsor of clinical trials, Radboud UMC leverages its multidisciplinary expertise to conduct high-quality research that aims to improve patient outcomes and enhance medical knowledge. The center is committed to ethical standards and regulatory compliance, fostering collaboration among researchers, healthcare professionals, and patients to translate scientific discoveries into effective clinical applications. With a focus on personalized medicine and cutting-edge technologies, Radboud University Medical Center plays a pivotal role in shaping the future of healthcare through its rigorous clinical trial initiatives.

Locations

Patients applied

0 patients applied

Trial Officials

Nynke Jager, Dr

Principal Investigator

Radboud University Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported