Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment

NCT06095895 | Completed

• 1 other identifier: NL85390.091.23
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics; Area Under Curve; Tacrolimus; Immunosuppressive Agents; Mycophenolic Acid

Outcome Measures

Primary Outcomes (2)

• Bias

  Mean prediction error

  1 year

• Precision

  Root mean squared error

  1 year

Interventions

venipuncture OTHER

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

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Kidney transplant patients using tacrolimus and/or mycophenolic acid
• Age between 0 and 18 years
• Indication for an AUC measurement - judgement of clinician

You may not qualify if:

• Incapacitated patients
• No informed consent
• Not proficient in the Dutch language

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500HB, Netherlands

Location

MeSH Terms

Interventions

Phlebotomy

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Nynke Jager, Dr

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: March 15, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 20, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

NL (1)