Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-30 @ 5:40 AM
Study NCT ID:
NCT05744635
Status:
RECRUITING
Last Update Posted:
2024-08-22
First Post:
2023-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Pharmacokinetic Profile of Tacrolimus Medications and Their Relation to Effectiveness and Safety in Liver Transplant Patients
Sponsor:
Chiesi Hungary Ltd.
Organization:
Study Overview
Official Title:
Assessment of the Pharmacokinetic Profile of Tacrolimus Medications in Liver Transplant Patients
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LTA
Brief 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
* 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
Detailed Description:
The primary aim of the study is to assess tolerability of LCPT and graft function within the 24-month observational period. Other objectives include the assessment of the intraindividual variability of the TL and TDD, the incidence of BK and cytomegalovirus infections, the incidence of graft insufficiency and acute and chronic graft rejection. There are few real-life studies available on maintenance treatment regimens in liver transplant patients throughout Europe, and these only focus on the healthcare resources' consumption. There is a lack of data describing the effectiveness of different drugs and their combinations in early maintenance immunosuppression in the real-life setting. Even less data is available of ISU (immunosuppression) drugs combinations' metabolism and its relation to effectiveness and safety, measured in liver transplant patients.
Given the above considerations we planned this non-interventional study (NIS) to assess pharmacokinetic parameters of LCPT and other tacrolimus containing medications and their relation to efficacy and tolerability in hepatic allograft recipients in a real-life setting.
Given the above considerations we planned this non-interventional study (NIS) to assess pharmacokinetic parameters of LCPT and other tacrolimus containing medications and their relation to efficacy and tolerability in hepatic allograft recipients in a real-life setting.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: