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Model-based Medication Dosing Assist for Tacrolimus in Kidney Transplantation

NCT07030660 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 357

Last updated 2025-06-22

No results posted yet for this study

Summary

The daily dosing of tacrolimus, the most important immunosuppressant used after kidney transplantation, is a rather complex process in which many factors can have an influence in each individual in a unique way and variable over time. Based on retrospective and simulation studies in many hundreds of kidney transplant patients at the UZ Leuven, we developed a computer program that, based on your individual characteristics (e.g. age, hematocrit, ...) and the routinely measured concentration of tacrolimus in blood, suggests an individual dose to the physician for the next administration of tacrolimus. The physician must always approve (i.e., "validate") the dose of tacrolimus suggested by the computer in the electronic medical prescription before effective administration may occur. This is true for all medications. The physician can also, at any time, not approve the computer-proposed dose of tacrolimus and determine a dose him/herself.

A preliminary study on historical data of more than 300 kidney transplant patients from the UZ Leuven showed that the computer program predicted the dosage of tacrolimus better, reaching the optimal blood concentrations faster and in a higher percentage of patients compared to the classical calculation of the dose.

The purpose of this validation project is to directly compare computer-assisted dosing with the dosing suggested by physicians in order to learn in whom computer-assisted dosing gives a clear additional benefit.

Practical implementation of the study. Fate will determine whether in your case, during the first 14 days (maximum) after transplantation, the dosage of tacrolimus is suggested by the computer program (and validated by the physician; 2/3 chance) or whether the dosage of tacrolimus is determined only by the physician (1/3 chance). The clinical course after kidney transplantation will be identical to all patients according to routine treatment and follow-up. No additional blood draws or other additional tests will be performed; the hospital stay will not be prolonged by this validation study and there are no costs associated with this study.

Possible risks: there are no risks in participating in this study since the dose of tacrolimus administered will always be approved by a doctor (medication can only be prescribed by a medical doctor), regardless of whether the computer program is used or not.

Conditions

  • Kidney Transplantation

Interventions

OTHER

Model-Informed Precision Dosing (MIPD)

Model-Informed Precision Dosing (MIPD) of tacrolimus in kidney transplantation

Sponsors & Collaborators

  • KU Leuven

    lead OTHER

Principal Investigators

  • Dirk Kuypers, MD, PhD · KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-11
Primary Completion
2025-03-28
Completion
2025-03-28

Countries

  • Belgium

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 NCT07030660 on ClinicalTrials.gov