MISSION: Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment

• Sponsor: Radboud University Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06095895
• Collaborator: (none)
• Enrollment: 30
• Anticipated Duration (Months): 15

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics; Area Under Curve; Tacrolimus; Immunosuppressive Agents; Mycophenolic Acid	Other: venipuncture

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Model Informed preciSion doSIng tO iNdividualise and Optimize Pharmacotherapeutic Treatment
• Anticipated Study Start Date: Nov 15, 2023
• Anticipated Primary Completion Date: Nov 15, 2024
• Anticipated Study Completion Date: Feb 15, 2025

Outcome Measures

Primary Outcome Measures

1. Bias [1 year]

   Mean prediction error

2. Precision [1 year]

   Root mean squared error

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Radboud University Medical Center

Investigators

• Principal Investigator: Nynke Jager, Dr, Radboud University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Radboud University Medical Center
• ClinicalTrials.gov Identifier: NCT06095895
• Other Study ID Numbers: NL85390.091.23
• First Posted: Oct 23, 2023
• Last Update Posted: Oct 23, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 23, 2023