Assessment of the Pharmacokinetic Profile of Tacrolimus Medications and Their Relation to Effectiveness and Safety in Liver Transplant Patients

Launched by CHIESI HUNGARY LTD. · Feb 15, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how different medications containing tacrolimus work in liver transplant patients. It aims to understand how well these medications are absorbed and used by the body, their effectiveness, and their safety. The researchers will monitor several factors, including liver function, kidney function, and the occurrence of any infections or rejection of the transplanted liver. They are also interested in how well patients stick to their medication schedules.

To participate in this study, individuals must be at least 18 years old and have received a liver or liver-kidney transplant. They should have been taking a tacrolimus-based medication for at least four weeks and have a specific blood level of the medication. Importantly, participants won’t need to attend extra visits or undergo additional tests outside of their regular medical care. This study will help improve our understanding of how different tacrolimus medications can be used safely and effectively in liver transplant patients.

Gender

ALL

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