Assessment of the Pharmacokinetic Profile of Tacrolimus Medications and Their Relation to Effectiveness and Safety in Liver Transplant Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tacrolimus.
- Who it may be relevant to
- Registry conditions: Liver Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hungary, Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of the Pharmacokinetic Profile of Tacrolimus Medications in Liver Transplant Patients
Overview
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
Detailed description
The primary aim of the study is to assess tolerability of LCPT and graft function within the 24-month observational period. Other objectives include the assessment of the intraindividual variability of the TL and TDD, the incidence of BK and cytomegalovirus infections, the incidence of graft insufficiency and acute and chronic graft rejection. There are few real-life studies available on maintenance treatment regimens in liver transplant patients throughout Europe, and these only focus on the healthcare resources' consumption. There is a lack of data describing the effectiveness of different drugs and their combinations in early maintenance immunosuppression in the real-life setting. Even less data is available of ISU (immunosuppression) drugs combinations' metabolism and its relation to effectiveness and safety, measured in liver transplant patients.
Given the above considerations we planned this non-interventional study (NIS) to assess pharmacokinetic parameters of LCPT and other tacrolimus containing medications and their relation to efficacy and tolerability in hepatic allograft recipients in a real-life setting.
Interventions
- Drug Tacrolimus
Tacrolimus received as part of routine clinical care
Primary outcome measures
- Pharmacokinetic profile TL [Time frame: 12 months]
- Pharmacokinetic profile TDD [Time frame: 12 months]
- Pharmacokinetic profile C/D [Time frame: 12 months]
Secondary outcome measures (11)
- Liver function GGT [Time frame: 12 months]
- Liver function AP [Time frame: 12 months]
- Liver function GOT [Time frame: 12 months]
- Liver function GPT [Time frame: 12 months]
- Renal function [Time frame: 12 months]
- Kinetics and function [Time frame: 12 months]
- Rejection [Time frame: 12 months]
- Virus infection [Time frame: 12 months]
- Variability [Time frame: 12 months]
- Adherence BAASIS [Time frame: 12 months]
- Adherence prescriptions [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Use of medications 2 weeks prior to enrolment, or the need for continuous use of medications that are known to significantly affect the pharmacokinetics of tacrolimus containing medications (as CYP3A4 inducers: rifampin, carbamazepine, phenobarbital, and phenytoin, or CYP3A4 inhibitors: erythromycin, ketoconazole, clarithromycin, and verapamil containing medication)
- Presence of the following comorbidities:
- Diseases affecting adherence to therapy (Chronic neurologic conditions, Psychiatric diseases)
- Diseases affecting drug absorption and metabolism (Inflammatory bowel disease, Chronic inflammatory diseases of bile ducts, Presence of ascites due to any disease)
- Patients on waiting list for re-transplantation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Hungary · 1 center
- Semmelweis University, Department of Surgery, Transplantation and Gastroenterology — Budapest
Slovenia · 1 center
- University Medical Center Ljubljana, Division of Internal Medicine, Department of Gastroen — Ljubljana
Identifiers
NCT: NCT05744635 · LTA_2022