Assessing how different tacrolimus medications affect liver transplant patients
Assessment of the Pharmacokinetic Profile of Tacrolimus Medications in Liver Transplant Patients
This study is testing how different types of tacrolimus medications affect liver transplant patients to see which one works best for their recovery and overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chiesi Hungary Ltd. Industry-sponsored |
| Locations | 2 sites (Budapest and 1 other locations) |
| Trial ID | NCT05744635 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the pharmacokinetic profiles of various tacrolimus-containing medications in patients who have undergone liver transplantation. It will evaluate differences in drug absorption and metabolism, changes in liver function and kidney filtration rates, and the incidence of acute graft rejection and infections during a 24-month period. The study will also assess patient adherence to therapy and the variability of drug concentrations in relation to their effectiveness and safety. By gathering real-world data, the study seeks to fill gaps in understanding the optimal use of tacrolimus in liver transplant patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have received a liver or simultaneous liver and kidney transplant and are on a tacrolimus regimen.
Not a fit: Patients who have had their liver transplant for more than six months or those with chronic graft insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved immunosuppressive therapy for liver transplant patients, enhancing graft survival and patient outcomes.
How similar studies have performed: While there are limited real-life studies on tacrolimus in liver transplant patients, this study aims to provide novel insights into its pharmacokinetics and effectiveness.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Budapest and 1 other locations
- Semmelweis University, Department of Surgery, Transplantation and Gastroenterology — Budapest, Hungary (Recruiting)
- University Medical Center Ljubljana, Division of Internal Medicine, Department of Gastroenterology — Ljubljana, Slovenia (Recruiting)
Study contacts
- Principal investigator: László Piros, MD, PhD — Semmelweis University, Department of Surgery, Transplantation and Gastroenterology, Budapest, Hungary
- Study coordinator: Ákos Szeredi, MD
- Email: a.szeredi@chiesi.com
- Phone: +36707772232
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.