NCT05744635 Assessment of the Pharmacokinetic Profile of Tacrolimus Medications and Their Relation to Effectiveness and Safety in Liver Transplant Patients
| NCT ID | NCT05744635 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chiesi Hungary Ltd. |
| Condition | Liver Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 110 participants |
| Start Date | 2023-05-10 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 110 participants in total. It began in 2023-05-10 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: 1. Patients ≥ 18 years of age 2. Patients after liver- or simultaneous liver and kidney transplantation 3. 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 4. Patients signed an informed consent form for use of their pseudonymised clinical data within the present non-interventional trial. Exclusion Criteria: 1. Participation in any clinical trial, 30 days prior to inclusion 2. The patients received liver allograft more than 6 months before inclusion 3. Hospitalisation due to infection, acute rejection, or graft disfunction 2 weeks prior to enrolment 4. Chronic graft insufficiency in the patient's history 5. 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) 6. Presence of the following comorbidities: 1. Diseases affecting adherence to therapy (Chronic neurologic conditions, Psychiatric diseases) 2. Diseases affecting drug absorption and metabolism (Inflammatory bowel disease, Chronic inflammatory diseases of bile ducts, Presence of ascites due to any disease) 7. Patients on waiting list for re-transplantation
Contact & Investigator
László Piros, MD, PhD
PRINCIPAL INVESTIGATOR
Semmelweis University, Department of Surgery, Transplantation and Gastroenterology, Budapest, Hungary
Frequently Asked Questions
Who can join the NCT05744635 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05744635 currently recruiting?
Yes, NCT05744635 is actively recruiting participants. Contact the research team at a.szeredi@chiesi.com for enrollment information.
Where is the NCT05744635 trial being conducted?
This trial is being conducted at Budapest, Hungary, Ljubljana, Slovenia.
Who is sponsoring the NCT05744635 clinical trial?
NCT05744635 is sponsored by Chiesi Hungary Ltd.. The principal investigator is László Piros, MD, PhD at Semmelweis University, Department of Surgery, Transplantation and Gastroenterology, Budapest, Hungary. The trial plans to enroll 110 participants.