Model-based Medication Dosing Assist for Tacrolimus in Kidney Transplantation

NCT07030660 | Completed

• 1 other identifier: UZ Leuven S63463
• Study Type: interventional
• Target: 357
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

MIPD; Model-Informed Precision Dosing; Tacrolimus; Kidney Transplantation; Therapeutic Drug Monitoring

Outcome Measures

Primary Outcomes (2)

• Time to reach 3 in-target tacrolimus concentrations in the 8 days following transplant.

  Time to reach 3 in-target tacrolimus concentrations in the 8 days following transplant.

  From enrollment to 8 days after transplantation

• Probability of Target Attainment (PTA) in the first 8 days (%)

  Probability of target tacrolimus range attainment in the first 8 days (%)

  From enrollment to 8 days after transplantation

Secondary Outcomes (2)

• Average fraction of tacrolimus concentrations in target range per patient

  From enrollment to 14 days after transplantation

• Overall squared log-distance from target tacrolimus concentration range

  From enrollment to 14 days after transplantation

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

Model-Informed Precision Dosing of tacrolimus

Other: Model-Informed Precision Dosing (MIPD)

Control arm

NO INTERVENTION

Physician-based dosing of tacrolimus

Interventions

Model-Informed Precision Dosing (MIPD) OTHER

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

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older
• single kidney transplantation
• treated with tacrolimus, mycophenolate mofetil and corticosteroids

You may not qualify if:

• combined organ transplantation
• ongoing tacrolimus treatment prior to study enrollment
• requirement for tacrolimus target concentration ranges outside the study range (12-15 ng/mL)

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• Faelens R, Luyckx N, Kuypers D, Bouillon T, Annaert P. Predicting model-informed precision dosing: A test-case in tacrolimus dose adaptation for kidney transplant recipients. CPT Pharmacometrics Syst Pharmacol. 2022 Mar;11(3):348-361. doi: 10.1002/psp4.12758. Epub 2022 Feb 2.

  PMID: 35020971 BACKGROUND

Study Officials

• Dirk Kuypers, MD, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Nephrology and Renal Transplantation

Model Details: Random allocation to computer-driven Model-Informed Precision Dosing or physician dosing

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 22, 2025
• Study Start: May 11, 2021
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months after publication of results and ending 3 years after publication of results
• Access Criteria: A proposal that describes planned analyses must be submitted and requires approval. A data sharing agreement (DTA) must be approved and signed by both parties.

Locations

BE (1)