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

NCT05744635 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2024-08-22

No results posted yet for this study

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

Conditions

  • Liver Failure

Interventions

DRUG

Tacrolimus

Tacrolimus received as part of routine clinical care

Sponsors & Collaborators

  • Chiesi Slovenija, d.o.o.

    collaborator INDUSTRY

  • Chiesi Hungary Ltd.

    lead INDUSTRY

Principal Investigators

  • László Piros, MD, PhD · Semmelweis University, Department of Surgery, Transplantation and Gastroenterology, Budapest, Hungary

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-10
Primary Completion
2026-03-01
Completion
2026-06-01
FDA Drug
Yes

Countries

  • Hungary
  • Slovenia

Study Locations

More Related Trials

Entities

Drugs

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 NCT05744635 on ClinicalTrials.gov