Assessment of the Pharmacokinetic Profile of Tacrolimus Medications and Their Relation to Effectiveness and Safety in Liver Transplant Patients
- Conditions
- Liver Failure
- Registration Number
- NCT05744635
- Lead Sponsor
- Chiesi Hungary Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria:<br><br> 1. Patients = 18 years of age<br><br> 2. Patients after liver- or simultaneous liver and kidney transplantation<br><br> 3. Having received a tacrolimus containing immunosuppressant therapeutic regimen at<br> least for four weeks (induction therapy), and TL is within 5-20 ng/ml before<br> inclusion<br><br> 4. Patients signed an informed consent form for use of their pseudonymised clinical<br> data within the present non-interventional trial.<br><br>Exclusion Criteria:<br><br> 1. Participation in any clinical trial, 30 days prior to inclusion<br><br> 2. The patients received liver allograft more than 6 months before inclusion<br><br> 3. Hospitalisation due to infection, acute rejection, or graft disfunction 2 weeks<br> prior to enrolment<br><br> 4. Chronic graft insufficiency in the patient's history<br><br> 5. Use of medications 2 weeks prior to enrolment, or the need for continuous use of<br> medications that are known to significantly affect the pharmacokinetics of<br> tacrolimus containing medications (as CYP3A4 inducers: rifampin, carbamazepine,<br> phenobarbital, and phenytoin, or CYP3A4 inhibitors: erythromycin, ketoconazole,<br> clarithromycin, and verapamil containing medication)<br><br> 6. Presence of the following comorbidities:<br><br> 1. Diseases affecting adherence to therapy (Chronic neurologic conditions,<br> Psychiatric diseases)<br><br> 2. Diseases affecting drug absorption and metabolism (Inflammatory bowel disease,<br> Chronic inflammatory diseases of bile ducts, Presence of ascites due to any<br> disease)<br><br> 7. Patients on waiting list for re-transplantation
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic profile TL;Pharmacokinetic profile TDD;Pharmacokinetic profile C/D
- Secondary Outcome Measures
Name Time Method Liver function GGT;Liver function AP;Liver function GOT;Liver function GPT;Renal function;Kinetics and function;Rejection;Virus infection;Variability;Adherence BAASIS;Adherence prescriptions