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RECRUITING
NCT05744635

Assessment of the Pharmacokinetic Profile of Tacrolimus Medications and Their Relation to Effectiveness and Safety in Liver Transplant Patients

Sponsor: Chiesi Hungary Ltd.

View on ClinicalTrials.gov

Summary

The goal of this observational study is oo compare the pharmacokinetic parameters of different tacrolimus containing medications in liver transplant patients. The main question\[s\] it aims to answer are: * Differences in pharmacokinetic parameters of tacrolimus containing medicinal products (TL, TDD and their ratio - C/D) * Changes in liver function parameters compared to baseline. * Change in the estimated glomerular filtration rate (eGFR) compared to baseline. * To assess the possible relation of liver function parameters and eGFR to C/D (blood concentration and daily dosage) * Incidence of acute graft rejection during the study * Incidence of BK and cytomegalovirus (CMV) infection during the study * To assess the intraindividual variability of the TL, TDD and the ratios of these parameters (C/D) * To assess the patient-adherence of therapy based on the BAASIS questionnaire, and prescription filled by individual patients, based on electronic health-care record. Participants will not have to undergo any additional clinical visits or tests except which are required in routine clinical care

Official title: Assessment of the Pharmacokinetic Profile of Tacrolimus Medications in Liver Transplant Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

110

Start Date

2023-05-10

Completion Date

2026-06-01

Last Updated

2024-08-22

Healthy Volunteers

Not specified

Conditions

Interventions

DRUG

Tacrolimus

Tacrolimus received as part of routine clinical care

Locations (2)

Semmelweis University, Department of Surgery, Transplantation and Gastroenterology

Budapest, Hungary

University Medical Center Ljubljana, Division of Internal Medicine, Department of Gastroenterology

Ljubljana, Slovenia