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
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.
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
Adult, liver (or concomittant liver-renal) transplant patients, receiving tacrolimus containing medications.
Cohort
Prospective
Tacrolimus
DrugTacrolimus received as part of routine clinical care
Pharmacokinetic profile TL
To compare the trough level (TL) of different tacrolimus containing medications to Envarsus at each visit
Pharmacokinetic profile TDD
To compare the total daily dose (TDD) of different tacrolimus containing medications to Envarsus at each visit
Pharmacokinetic profile C/D
To compare the ration of TL and TDD (C/D) of different tacrolimus containing medications to Envarsus at each visit
Liver function GGT
Changes in Gamma glutamine transferase (GGT) levels compared to baseline.
Liver function AP
Changes in Alcalic phosphatase (AP) levels compared to baseline.
Liver function GOT
Changes in Glutamyl oxaloacetic transaminase (GOT) levels compared to baseline.
Liver function GPT
Changes in Glutamyl pyruvic transaminase (GPT) levels compared to baseline.
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Chiesi Hungary Ltd.
Lead sponsor
Chiesi Slovenija, d.o.o.
Collaborator
