Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-31 @ 6:30 PM
Study NCT ID:
NCT01011205
Status:
COMPLETED
Last Update Posted:
2024-11-01
First Post:
2009-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation
Sponsor:
Organization:
Raw JSON
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'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 893}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2013-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-30', 'studyFirstSubmitDate': '2009-11-10', 'studyFirstSubmitQcDate': '2009-11-10', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glomerular filtration rate (GFR) at 24 Weeks after transplantation estimated using the MDRD4 formula', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Incidence of and time to first incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR)', 'timeFrame': '24 weeks'}, {'measure': 'GFR at 24 Weeks after transplantation measured by Iothalamate clearance', 'timeFrame': '24 weeks'}, {'measure': 'GFR at 24 Weeks after transplantation estimated using a Cystatin C based formula', 'timeFrame': '24 weeks'}, {'measure': 'Creatinine clearance at 24 Weeks after transplantation estimated using the Cockcroft and Gault formula', 'timeFrame': '24 weeks'}, {'measure': 'Incidence of and time to first incidence of acute rejection', 'timeFrame': '24 weeks'}, {'measure': 'Incidence of and time to first incidence of corticosteroid-resistant acute rejection', 'timeFrame': '24 weeks'}, {'measure': 'Overall frequency of acute rejection episodes', 'timeFrame': '24 weeks'}, {'measure': 'Incidence of and time to first incidence of biopsy confirmed acute rejection', 'timeFrame': '24 weeks'}, {'measure': 'Incidence of and time to first incidence of biopsy confirmed corticosteroid-resistant acute rejection', 'timeFrame': '24 weeks'}, {'measure': 'Overall frequency of biopsy confirmed acute rejection episodes', 'timeFrame': '24 weeks'}, {'measure': 'Severity of biopsy confirmed acute rejection episodes', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Immunosuppression', 'Liver', 'Transplant', 'Advagraf'], 'conditions': ['Liver Transplantation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.astellasclinicalstudyresults.com/study.aspx?ID=57', 'label': 'Link to results on Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which may have the potential to cause fewer kidney problems.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing orthotopic liver or split liver allograft transplantation\n* Female subject of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain effective birth control during the study\n\nExclusion Criteria:\n\n* Receiving a multi-organ transplant or having previous received an organ transplant (including liver re-transplantation)\n* Receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used\n* Receiving ABO incompatible graft or a graft from a non heart beating donor\n* Ongoing dosing with systemic corticosteroids\n* Subjects with systemic infection requiring treatment except viral hepatitis\n* Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully. However, subjects with primary liver carcinoma can be included if they meet the following criteria:\n\n * \\< 3 nodes\n * no node larger than 5 cm\n * no metastases\n * no vascular tumoral invasion\n* Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer\n* Subject or donor known to be HIV positive\n* Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, basiliximab or mycophenolate mofetil or any of the product excipients\n* Pregnant woman or breast-feeding mother\n* Currently participating in another clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment\n* Unlikely to comply with the Visits scheduled in the protocol\n* Any unstable medical condition that could interfere with the study objectives in the opinion of the Investigator\n* Receiving prohibited concomitant therapy, or received prohibited concomitant therapy within 28 days prior to enrollment\n* Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the Investigator, may complicate communication with the Investigator'}, 'identificationModule': {'nctId': 'NCT01011205', 'acronym': 'DIAMOND', 'briefTitle': 'Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Multicenter, Three Arm, Randomized, Open Label Clinical Study to Compare Renal Function in Liver Transplant Recipients Receiving an Immunosuppressive Regimen of Advagraf (Immediately or Delayed Post-transplant) and MMF With or Without a Monoclonal Anti-IL2R Antibody (Basiliximab)', 'orgStudyIdInfo': {'id': 'PMR-EC-1106'}, 'secondaryIdInfos': [{'id': '2008-002231-32', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}, {'id': '2010-021075-89', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dosing Regimen 1', 'description': 'Advagraf + MMF + Corticosteroids (Bolus)', 'interventionNames': ['Drug: Advagraf', 'Drug: Mycophenolate Mofetil', 'Drug: Corticosteroids']}, {'type': 'EXPERIMENTAL', 'label': 'Dosing Regimen 2', 'description': 'Advagraf + MMF + Basiliximab + Corticosteroids (Bolus)', 'interventionNames': ['Drug: Advagraf', 'Drug: Mycophenolate Mofetil', 'Drug: Basiliximab', 'Drug: Corticosteroids']}, {'type': 'EXPERIMENTAL', 'label': 'Dosing Regimen 3', 'description': 'Advagraf (5 days delay) + MMF + Basiliximab + Corticosteroids (Bolus)', 'interventionNames': ['Drug: Advagraf', 'Drug: Mycophenolate Mofetil', 'Drug: Basiliximab', 'Drug: Corticosteroids']}], 'interventions': [{'name': 'Advagraf', 'type': 'DRUG', 'otherNames': ['MR4', 'FK506E', 'tacrolimus modified release'], 'description': 'Capsule', 'armGroupLabels': ['Dosing Regimen 1', 'Dosing Regimen 2', 'Dosing Regimen 3']}, {'name': 'Mycophenolate Mofetil', 'type': 'DRUG', 'otherNames': ['MMF'], 'description': 'Solution for infusion', 'armGroupLabels': ['Dosing Regimen 1', 'Dosing Regimen 2', 'Dosing Regimen 3']}, {'name': 'Basiliximab', 'type': 'DRUG', 'otherNames': ['Simulect'], 'description': 'IV infusion', 'armGroupLabels': ['Dosing Regimen 2', 'Dosing Regimen 3']}, {'name': 'Corticosteroids', 'type': 'DRUG', 'otherNames': ['Methylprednisolone or equivalent'], 'description': 'IV bolus', 'armGroupLabels': ['Dosing Regimen 1', 'Dosing Regimen 2', 'Dosing Regimen 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'facility': '160', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': '001', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '220116', 'city': 'Minsk', 'country': 'Belarus', 'facility': '146', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 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addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.", 'accessCriteria': 'Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}