Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-29 @ 2:20 AM
Study NCT ID:
NCT01339468
Status:
COMPLETED
Last Update Posted:
2017-07-19
First Post:
2011-04-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016559', 'term': 'Tacrolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2014-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-17', 'studyFirstSubmitDate': '2011-04-12', 'studyFirstSubmitQcDate': '2011-04-19', 'lastUpdatePostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-24 (Area under the curve for 24 hours) of tacrolimus plasma concentration', 'timeFrame': 'Day 6 and day 21'}], 'secondaryOutcomes': [{'measure': 'Cmax (maximum concentration) of tacrolimus plasma concentration', 'timeFrame': 'Day 6 and day 21'}, {'measure': 'Incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR)', 'timeFrame': 'up to 24 weeks'}, {'measure': 'Time to first incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR)', 'timeFrame': 'up to 24 weeks'}, {'measure': 'Safety assessed by the incidence of adverse events and lab-tests', 'timeFrame': 'up to 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['advagraf', 'prograf', 'living donor liver transplantation', 'FK506', 'Immunosuppressant'], 'conditions': ['Liver Transplantation']}, 'referencesModule': {'references': [{'pmid': '30098071', 'type': 'DERIVED', 'citation': 'Shin MH, Song GW, Lee SG, Hwang S, Kim KH, Ahn CS, Moon DB, Ha TY, Jung DH, Park GC, Yun YI, Kim WJ, Kang WH, Kim SH, Jiang H, Lee S, Tak EY. Once-daily, prolonged-release tacrolimus vs twice-daily, immediate-release tacrolimus in de novo living-donor liver transplantation: A Phase 4, randomized, open-label, comparative, single-center study. Clin Transplant. 2018 Sep;32(9):e13376. doi: 10.1111/ctr.13376. Epub 2018 Aug 26.'}], 'seeAlsoLinks': [{'url': 'https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=131', 'label': 'Link to results on Astellas Clinical Study Results website'}, {'url': 'https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=130', 'label': 'Link to results on Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate and compare the pharmacokinetic parameters of tacrolimus from Advagraf and Prograf in de nove living donor liver transplant recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subject receiving a primary, partial liver graft from a living donor\n* subject must receive the first dose of tacrolimus and corticosteroids after operation and are expected to be maintained on tacrolimus throughout the study. MMF could be combined\n\nExclusion Criteria:\n\n* subjects receiving a multi-organ transplant or having previously received an organ transplant (including liver re-transplantation)\n* subjects receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used\n* subjects allergic or intolerant to macrolide antibiotics or tacrolimus\n* subjects requiring immunosuppressive treatment and / or systemic chemotherapy prior to transplantation\n* subjects with malignancies or a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin\n* subjects with systemic infection requiring treatment, except viral hepatitis\n* subjects with severe diarrhoea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus\n* subjects with serum creatinine \\> 1.5mg/dl\n* subjects taking or having taken potassium preserved diuretics\n* subjects with any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator\n* subjects participating or having participated in another clinical trial and/or those taking or having taken an investigational / non-registered drug in the past 28 days\n* subjects or donors known to be HIV positive\n* donors known to be HBV, HCV positive and/or IgM positive of CMV, EBV'}, 'identificationModule': {'nctId': 'NCT01339468', 'acronym': 'MAIN', 'briefTitle': 'A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase IV, Randomized, Open-label, Comparative, Single-center Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf® (Modified Release Tacrolimus) and Prograf® (Tacrolimus) in de Novo Living Donor Liver Transplant Recipients', 'orgStudyIdInfo': {'id': 'MR-08-04-KOR_Main'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Intravenous Prograf therapy followed by oral Advagraf therapy', 'interventionNames': ['Drug: Advagraf', 'Drug: Prograf']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'Intravenous Prograf therapy followed by oral Prograf therapy', 'interventionNames': ['Drug: Prograf']}], 'interventions': [{'name': 'Advagraf', 'type': 'DRUG', 'otherNames': ['FK506E', 'modified release tacrolimus'], 'description': 'oral', 'armGroupLabels': ['Arm 1']}, {'name': 'Prograf', 'type': 'DRUG', 'otherNames': ['FK506', 'tacrolimus'], 'description': 'oral', 'armGroupLabels': ['Arm 2']}, {'name': 'Prograf', 'type': 'DRUG', 'otherNames': ['tacrolimus', 'FK506'], 'description': 'intravenous', 'armGroupLabels': ['Arm 1', 'Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Use Central Contact', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}