Actively Recruiting
Assessment of the Pharmacokinetic Profile of Tacrolimus Medications in Liver Transplant Patients
Led by Chiesi Hungary Ltd. · Updated on 2024-08-22
110
Participants Needed
2
Research Sites
13 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
This observational study focuses on liver transplant patients who are taking tacrolimus-containing medications. It aims to compare the pharmacokinetic parameters of different tacrolimus products and examine their relationships to liver function, kidney function (estimated glomerular filtration rate), and patient adherence. The study also monitors the occurrence of acute graft rejection and infections such as BK and cytomegalovirus during the observation period. This research addresses the lack of real-life data on immunosuppressive drug effectiveness and safety in liver transplant patients across Europe. Participants are liver or simultaneous liver-kidney transplant recipients aged 18 years or older who have been on tacrolimus-containing immunosuppressant therapy for at least four weeks before joining. Various tacrolimus medications, including Envarsus, Adport, Advagraf, Modigraf, Prograf, and Tacforius, are used under routine clinical care following local dosing guidelines. The study observes patients over a 24-month period without changing their prescribed treatments. During the study, participants undergo routine clinical visits and tests as part of their standard care, with no additional procedures required. Researchers collect data on tacrolimus blood levels, daily doses, and their variability, alongside liver and kidney function tests. Adherence is assessed using the BAASIS questionnaire and electronic health records of prescription fills. Outcomes such as graft rejection, infection rates, and drug tolerability are evaluated over 12 months, with ongoing monitoring for up to two years.
CONDITIONS
Brief 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 had a liver or simultaneous liver and kidney transplant
- Patients who have received tacrolimus-containing immunosuppressant therapy for at least four weeks
- Tacrolimus blood level between 5 and 20 ng/ml before joining
- Signed informed consent for use of pseudonymised clinical data in this study
You will not qualify if you...
- Participation in any other clinical trial within 30 days before joining
- Liver transplant performed more than 6 months before joining
- Hospitalization due to infection, acute rejection, or graft dysfunction within 2 weeks before joining
- History of chronic graft insufficiency
- Use or need for continuous use of medications that affect tacrolimus metabolism within 2 weeks before joining (such as certain enzyme inducers or inhibitors)
- Presence of diseases affecting therapy adherence (including chronic neurological or psychiatric conditions)
- Presence of diseases affecting drug absorption or metabolism (such as inflammatory bowel disease, chronic bile duct inflammation, or ascites)
- Patients on waiting list for re-transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants who receive tacrolimus as part of routine clinical care are observed to assess drug pharmacokinetics, liver and renal function, graft status, infections, and medication adherence over time.
Regular visits according to routine clinical care over 24 months
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
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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