Assessment of the Pharmacokinetic Profile of Tacrolimus Medications in Liver Transplant Patients

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• Patients ≥ 18 years of age

• Patients after liver- or simultaneous liver and kidney transplantation

• 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

• Patients signed an informed consent form for use of their pseudonymised clinical data within the present non-interventional trial.

Locations
Other Locations
Hungary
Semmelweis University, Department of Surgery, Transplantation and Gastroenterology
RECRUITING
Budapest
Slovenia
University Medical Center Ljubljana, Division of Internal Medicine, Department of Gastroenterology
RECRUITING
Ljubljana
Contact Information
Primary
Ákos Szeredi, MD
a.szeredi@chiesi.com
+36707772232
Time Frame
Start Date: 2023-05-10
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 110
Treatments
Liver transplant patients, receiving tacrolimus containing immunosuppression
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. Possible medications are the following (dosages and administration according to local (European) SmPC~ * Envarsus prolonged release tablet~ * Adport hard capsule~ * Advagraf prolonged-release hard capsule~ * Modigraf granule for oral suspension~ * Prograf hard capsule~ * Tacforius hard capsule
Sponsors
Leads: Chiesi Hungary Ltd.
Collaborators: Chiesi Slovenija, d.o.o.

This content was sourced from clinicaltrials.gov