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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017093', 'term': 'Liver Failure'}], 'ancestors': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2023-01-30', 'studyFirstSubmitQcDate': '2023-02-15', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic profile TL', 'timeFrame': '12 months', 'description': 'To compare the trough level (TL) of different tacrolimus containing medications to Envarsus at each visit'}, {'measure': 'Pharmacokinetic profile TDD', 'timeFrame': '12 months', 'description': 'To compare the total daily dose (TDD) of different tacrolimus containing medications to Envarsus at each visit'}, {'measure': 'Pharmacokinetic profile C/D', 'timeFrame': '12 months', 'description': 'To compare the ration of TL and TDD (C/D) of different tacrolimus containing medications to Envarsus at each visit'}], 'secondaryOutcomes': [{'measure': 'Liver function GGT', 'timeFrame': '12 months', 'description': 'Changes in Gamma glutamine transferase (GGT) levels compared to baseline.'}, {'measure': 'Liver function AP', 'timeFrame': '12 months', 'description': 'Changes in Alcalic phosphatase (AP) levels compared to baseline.'}, {'measure': 'Liver function GOT', 'timeFrame': '12 months', 'description': 'Changes in Glutamyl oxaloacetic transaminase (GOT) levels compared to baseline.'}, {'measure': 'Liver function GPT', 'timeFrame': '12 months', 'description': 'Changes in Glutamyl pyruvic transaminase (GPT) levels compared to baseline.'}, {'measure': 'Renal function', 'timeFrame': '12 months', 'description': 'Change in the estimated glomerular filtration rate (eGFR) compared to baseline.'}, {'measure': 'Kinetics and function', 'timeFrame': '12 months', 'description': 'To assess the possible relation of liver function parameters and eGFR to C/D (blood concentration and daily dosage)'}, {'measure': 'Rejection', 'timeFrame': '12 months', 'description': 'Incidence of acute graft rejection during the study'}, {'measure': 'Virus infection', 'timeFrame': '12 months', 'description': 'Incidence of BK and cytomegalovirus (CMV) infection during the study'}, {'measure': 'Variability', 'timeFrame': '12 months', 'description': 'To assess the intraindividual variability of the TL, TDD and the ratios of these parameters (C/D)'}, {'measure': 'Adherence BAASIS', 'timeFrame': '12 months', 'description': 'To assess the patient-adherence of therapy based on the BAASIS questionnaire'}, {'measure': 'Adherence prescriptions', 'timeFrame': '12 months', 'description': 'To assess the patient-adherence of therapy based on the prescription filled by individual patients, based on electronic health-care record.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver transplantation', 'Immunosuppression', 'Tacrolimus'], 'conditions': ['Liver Failure']}, 'descriptionModule': {'briefSummary': '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:\n\n* Differences in pharmacokinetic parameters of tacrolimus containing medicinal products (TL, TDD and their ratio - C/D)\n* Changes in liver function parameters compared to baseline.\n* Change in the estimated glomerular filtration rate (eGFR) compared to baseline.\n* To assess the possible relation of liver function parameters and eGFR to C/D (blood concentration and daily dosage)\n* Incidence of acute graft rejection during the study\n* Incidence of BK and cytomegalovirus (CMV) infection during the study\n* To assess the intraindividual variability of the TL, TDD and the ratios of these parameters (C/D)\n* To assess the patient-adherence of therapy based on the BAASIS questionnaire, and prescription filled by individual patients, based on electronic health-care record.\n\nParticipants will not have to undergo any additional clinical visits or tests except which are required in routine clinical care', 'detailedDescription': "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.\n\nGiven 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult, liver (or concomittant liver-renal) transplant patients, receiving tacrolimus containing medications.', 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients ≥ 18 years of age\n2. Patients after liver- or simultaneous liver and kidney transplantation\n3. 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\n4. Patients signed an informed consent form for use of their pseudonymised clinical data within the present non-interventional trial.\n\nExclusion Criteria:\n\n1. Participation in any clinical trial, 30 days prior to inclusion\n2. The patients received liver allograft more than 6 months before inclusion\n3. Hospitalisation due to infection, acute rejection, or graft disfunction 2 weeks prior to enrolment\n4. Chronic graft insufficiency in the patient's history\n5. 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)\n6. Presence of the following comorbidities:\n\n 1. Diseases affecting adherence to therapy (Chronic neurologic conditions, Psychiatric diseases)\n 2. Diseases affecting drug absorption and metabolism (Inflammatory bowel disease, Chronic inflammatory diseases of bile ducts, Presence of ascites due to any disease)\n7. Patients on waiting list for re-transplantation"}, 'identificationModule': {'nctId': 'NCT05744635', 'acronym': 'LTA', 'briefTitle': 'Assessment of the Pharmacokinetic Profile of Tacrolimus Medications and Their Relation to Effectiveness and Safety in Liver Transplant Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chiesi Hungary Ltd.'}, 'officialTitle': 'Assessment of the Pharmacokinetic Profile of Tacrolimus Medications in Liver Transplant Patients', 'orgStudyIdInfo': {'id': 'LTA_2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Liver transplant patients, receiving tacrolimus containing immunosuppression', 'description': '1. Patients ≥ 18 years of age\n2. Patients after liver- or simultaneous liver and kidney transplantation\n3. 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\n\n * Envarsus prolonged release tablet\n * Adport hard capsule\n * Advagraf prolonged-release hard capsule\n * Modigraf granule for oral suspension\n * Prograf hard capsule\n * Tacforius hard capsule', 'interventionNames': ['Drug: Tacrolimus']}], 'interventions': [{'name': 'Tacrolimus', 'type': 'DRUG', 'description': 'Tacrolimus received as part of routine clinical care', 'armGroupLabels': ['Liver transplant patients, receiving tacrolimus containing immunosuppression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1085', 'city': 'Budapest', 'status': 'RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'László Piros, MD, PhD', 'role': 'CONTACT', 'email': 'drpiroslaszlo@gmail.com', 'phone': '+36300905499'}, {'name': 'Tamás Benkő, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anita Haboub Sandil, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Semmelweis University, Department of Surgery, Transplantation and Gastroenterology', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1000', 'city': 'Ljubljana', 'status': 'RECRUITING', 'country': 'Slovenia', 'contacts': [{'name': 'Marija Ribnikar, MD, PhD', 'role': 'CONTACT'}, {'name': 'Katja Novak, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jan Drnovsek, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anja Rihtarsic, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marjana Turk Jerovsek, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Medical Center Ljubljana, Division of Internal Medicine, Department of Gastroenterology', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'centralContacts': [{'name': 'Ákos Szeredi, MD', 'role': 'CONTACT', 'email': 'a.szeredi@chiesi.com', 'phone': '+36707772232'}], 'overallOfficials': [{'name': 'László Piros, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Semmelweis University, Department of Surgery, Transplantation and Gastroenterology, Budapest, Hungary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiesi Hungary Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Chiesi Slovenija, d.o.o.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}