Actively Recruiting
Assessment of the Pharmacokinetic Profile of Tacrolimus Medications and Their Relation to Effectiveness and Safety in Liver Transplant Patients
Led by Chiesi Hungary Ltd. · Updated on 2024-08-22
110
Participants Needed
2
Research Sites
159 weeks
Total Duration
On this page
Sponsors
C
Chiesi Hungary Ltd.
Lead Sponsor
C
Chiesi Slovenija, d.o.o.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Assessment of the Pharmacokinetic Profile of Tacrolimus Medications and Their Relation to Effectiveness and Safety in Liver Transplant Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Patients who have received a liver or simultaneous liver and kidney transplant
- Patients who have been on a tacrolimus-containing immunosuppressant regimen for at least four weeks with tacrolimus levels between 5 and 20 ng/ml before joining
- Patients who have signed informed consent to use their pseudonymized clinical data for this study
You will not qualify if you...
- Participation in any clinical trial within 30 days before joining
- Liver transplant occurred more than 6 months before joining
- Hospitalization for infection, acute rejection, or graft dysfunction within 2 weeks before enrollment
- History of chronic graft insufficiency
- Use or need of medications within 2 weeks before enrollment that significantly affect tacrolimus pharmacokinetics (e.g., certain CYP3A4 inducers or inhibitors)
- Presence of diseases affecting therapy adherence such as chronic neurological or psychiatric conditions
- Presence of diseases affecting drug absorption or metabolism, including inflammatory bowel disease, chronic inflammatory bile duct diseases, or ascites
- Being on the waiting list for re-transplantation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Semmelweis University, Department of Surgery, Transplantation and Gastroenterology
Budapest, Hungary, 1085
Actively Recruiting
2
University Medical Center Ljubljana, Division of Internal Medicine, Department of Gastroenterology
Ljubljana, Slovenia, 1000
Actively Recruiting
Research Team
Á
Ákos Szeredi, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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