About this trial
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
Eligibility criteria
Qualifiers
Patients ≥ 18 years of age
Patients after liver- or simultaneous liver and kidney transplantation
Having received a tacrolimus containing immunosuppressant therapeutic regimen at least for four weeks (induction therapy), and TL is within 5-20 ng/ml before inclusion
Patients signed an informed consent form for use of their pseudonymised clinical data within the present non-interventional trial.
Disqualifiers
Participation in any clinical trial, 30 days prior to inclusion
The patients received liver allograft more than 6 months before inclusion
Hospitalisation due to infection, acute rejection, or graft disfunction 2 weeks prior to enrolment
Chronic graft insufficiency in the patient's history
Trial design
Treatments tested in this trial
- Tacrolimus
Treatment groups
Sponsors and collaborators
Chiesi Hungary Ltd.
Lead sponsor
Chiesi Slovenija, d.o.o.
Collaborator