Liver FailureLTANCT05744635
Assessment of the Pharmacokinetic Profile of Tacrolimus Medications and Their Relation to Effectiveness and Safety in Liver Transplant Patients
An observational study of Liver Failure, run by Chiesi Hungary Ltd. at 2 sites in 2 countries.
Trial 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 … Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Failure
- What is being tested?
- Tacrolimus
- Type of treatment
- Pill or oral medicine
- How many people
- 110 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 May 2023to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult, liver (or concomittant liver-renal) transplant patients, receiving tacrolimus containing medications.
Who may be able to join
- 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.
Who cannot join
- Participation in any clinical trial, 30 days prior to inclusion
- The patients received liver allograft more than 6 months before inclusion
- Hospitalisation due to infection, acute rejection, or graft disfunction 2 weeks prior to enrolment
- Chronic graft insufficiency in the patient's history
- 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)
- Presence of the following comorbidities:
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- Diseases affecting adherence to therapy (Chronic neurologic conditions, Psychiatric diseases)
- Diseases affecting drug absorption and metabolism (Inflammatory bowel disease, Chronic inflammatory diseases of bile ducts, Presence of ascites due to any disease)
- Patients on waiting list for re-transplantation
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University, Department of Surgery, Transplantation and Gastroenterology
Budapest, 1085
László Piros, MD, PhD, +36300905499, drpiroslaszlo@gmail.com
Tamás Benkő, MD, PhD
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Center Ljubljana, Division of Internal Medicine, Department of Gastroenterology
Ljubljana, 1000
Marija Ribnikar, MD, PhD
Katja Novak, MD
About this study
Official title: Assessment of the Pharmacokinetic Profile of Tacrolimus Medications in Liver Transplant Patients
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
Read the 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.
- Conditions
- Liver Failure
- Being tested
- Tacrolimus
- Keywords
- Liver transplantation, Immunosuppression, Tacrolimus
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Tacrolimus received as part of routine clinical care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic profile TL
To compare the trough level (TL) of different tacrolimus containing medications to Envarsus at each visit
Measured: 12 months
Pharmacokinetic profile TDD
To compare the total daily dose (TDD) of different tacrolimus containing medications to Envarsus at each visit
Measured: 12 months
Pharmacokinetic profile C/D
To compare the ration of TL and TDD (C/D) of different tacrolimus containing medications to Envarsus at each visit
Measured: 12 months
Secondary outcomes (11)
Liver function GGT
Changes in Gamma glutamine transferase (GGT) levels compared to baseline.
Measured: 12 months
Liver function AP
Changes in Alcalic phosphatase (AP) levels compared to baseline.
Measured: 12 months
Liver function GOT
Changes in Glutamyl oxaloacetic transaminase (GOT) levels compared to baseline.
Measured: 12 months
Liver function GPT
Changes in Glutamyl pyruvic transaminase (GPT) levels compared to baseline.
Measured: 12 months
Renal function
Change in the estimated glomerular filtration rate (eGFR) compared to baseline.
Measured: 12 months
Kinetics and function
To assess the possible relation of liver function parameters and eGFR to C/D (blood concentration and daily dosage)
Measured: 12 months
Rejection
Incidence of acute graft rejection during the study
Measured: 12 months
Virus infection
Incidence of BK and cytomegalovirus (CMV) infection during the study
Measured: 12 months
Variability
To assess the intraindividual variability of the TL, TDD and the ratios of these parameters (C/D)
Measured: 12 months
Adherence BAASIS
To assess the patient-adherence of therapy based on the BAASIS questionnaire
Measured: 12 months
Adherence prescriptions
To assess the patient-adherence of therapy based on the prescription filled by individual patients, based on electronic health-care record.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start10 May 2023
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi Hungary Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chiesi Slovenija, d.o.o.
- Responsible party
- Sponsor
- Investigators
- László Piros, MD, PhD, Principal investigator, Semmelweis University, Department of Surgery, Transplantation and Gastroenterology, Budapest, Hungary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744635
- Sponsor's protocol ID
- LTA_2022
- Acronym
- LTA
- Status last verified
- Aug 2024
- First submitted
- 30 Jan 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Pharmacokinetic Profile of Tacrolimus Medications in Liver Transplant Patients
- ClinicalTrials.gov ID
- NCT05744635
- Acronym / sponsor ID
- LTA / LTA_2022
- Conditions
- Liver Failure
- Keywords
- Liver transplantation, Immunosuppression, Tacrolimus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Chiesi Hungary Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Chiesi Slovenija, d.o.o.
- Study start
- 10 May 2023 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplant patients, receiving tacrolimus containing immunosuppression | – | Drug: Tacrolimus1. 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult, liver (or concomittant liver-renal) transplant patients, receiving tacrolimus containing medications.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- Participation in any clinical trial, 30 days prior to inclusion
- The patients received liver allograft more than 6 months before inclusion
- Hospitalisation due to infection, acute rejection, or graft disfunction 2 weeks prior to enrolment
- Chronic graft insufficiency in the patient's history
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TacrolimusTacrolimus received as part of routine clinical care | Drug | Liver transplant patients, receiving tacrolimus containing immunosuppression |
Primary outcome
Pharmacokinetic profile TL
Time frame: 12 months
To compare the trough level (TL) of different tacrolimus containing medications to Envarsus at each visit
Pharmacokinetic profile TDD
Time frame: 12 months
To compare the total daily dose (TDD) of different tacrolimus containing medications to Envarsus at each visit
Pharmacokinetic profile C/D
Time frame: 12 months
To compare the ration of TL and TDD (C/D) of different tacrolimus containing medications to Envarsus at each visit
11 secondary outcomes
Liver function GGT
Time frame: 12 months
Liver function AP
Time frame: 12 months
Liver function GOT
Time frame: 12 months
Liver function GPT
Time frame: 12 months
Renal function
Time frame: 12 months
Kinetics and function
Time frame: 12 months
Rejection
Time frame: 12 months
Virus infection
Time frame: 12 months
Variability
Time frame: 12 months
Adherence BAASIS
Time frame: 12 months
Adherence prescriptions
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Liver Failure
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
László Piros, MD, PhD principal investigator
Semmelweis University, Department of Surgery, Transplantation and Gastroenterology, Budapest, Hungary
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Failure, run by Chiesi Hungary Ltd. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ákos Szeredi, MD (+36707772232, a.szeredi@chiesi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic profile TL (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.