Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-28 @ 9:43 PM
Study NCT ID:
NCT00557518
Status:
TERMINATED
Last Update Posted:
2009-01-30
First Post:
2007-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Alagebrium in Patients With Insulin-Dependent Type 1 Diabetes and Microalbuminuria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003928', 'term': 'Diabetic Nephropathies'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C406794', 'term': 'alagebrium'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'whyStopped': 'Study has been terminated early due to financial constraints.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2009-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-01-29', 'studyFirstSubmitDate': '2007-11-12', 'studyFirstSubmitQcDate': '2007-11-13', 'lastUpdatePostDateStruct': {'date': '2009-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in albumin excretion rate (µg/min)', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Albumin:creatinine ratio(mg/g), plasma renin level, collagen markers, AGE related markers, 24 hour blood pressure determinations', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1', 'Diabetic Nephropathy']}, 'descriptionModule': {'briefSummary': 'Based upon the preclinical evidence in models of diabetic nephropathy under conditions approximating both type I and II diabetes, treatment with alagebrium appears to have favorable and advantageous effects on the biochemical, structural, pathological and functional hallmarks of diabetic nephropathy. The renoprotective effects of alagebrium in preclinical models favor the evaluation of this drug in patients with type I diabetes.', 'detailedDescription': 'This study is a double-blind, randomized, placebo-controlled, parallel design trial enrolling 80 patients (2x40) with Type 1 diabetes and microalbuminuria. Patients will be randomized to either 200 mg Alagebrium twice daily or placebo for a period of 24 weeks after an 8 week run-in period. There will be a 8 week run-out period. All patients will receive ramipril during the entire study period. Efficacy measurements will be performed at baseline, at 12 weeks and at the end of the study. Measurements for albumin:creatinine ratio(mg/g), plasma renin level, collagen markers, AGE related markers and 24 hour blood pressure measurements will also be determined. A total of 9 visits will be performed during the entire study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Insulin-dependent type 1 diabetes\n* Age 18-65 years\n* Diagnosis of established microalbuminuria\n* Blood pressure \\<140 mm Hg, diastolic blood pressure \\<90 mm Hg\n* HbA1c \\<10%\n\nExclusion Criteria:\n\n* Body mass index \\>40 kg/m2\n* Cardiovascular event within 6 months prior to screening\n* History of acute myocardial infarction within 12 months prior to screening\n* Serum creatinine \\>1.5 mg/dL\n* Receiving chronic nonsteroidal anti-inflammatory therapy\n* Receiving antihypertensive therapy except for angiotensin converting enzyme inhibitors or angiotensin receptor blockers\n* Any significant systemic illnesses,medical conditions or abnormal laboratory values'}, 'identificationModule': {'nctId': 'NCT00557518', 'briefTitle': 'Study of Alagebrium in Patients With Insulin-Dependent Type 1 Diabetes and Microalbuminuria', 'organization': {'class': 'INDUSTRY', 'fullName': 'Synvista Therapeutics, Inc'}, 'officialTitle': 'A Randomized, Placebo-Controlled Trial of Alagebrium in Patients With Insulin-Dependent Type 1 Diabetes and Microalbuminuria', 'orgStudyIdInfo': {'id': 'ALT-711-0424'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Alagebrium']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Alagebrium', 'type': 'DRUG', 'otherNames': ['ALT-711'], 'description': '200 mg bid', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'bid', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '3162', 'city': 'Caulfield', 'state': 'Victoria', 'country': 'Australia', 'facility': 'International Diabetes Institute', 'geoPoint': {'lat': -37.88251, 'lon': 145.02288}}, {'zip': '3220', 'city': 'Geelong', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Dept. of Clinical and Biomedical Science Myers House', 'geoPoint': {'lat': -38.14711, 'lon': 144.36069}}, {'zip': '3084', 'city': 'Heidelburg', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Austin Health'}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': 'DK-2820', 'city': 'Gentofte Municipality', 'country': 'Denmark', 'facility': 'Steno Diabetes Center', 'geoPoint': {'lat': 55.74903, 'lon': 12.54601}}], 'overallOfficials': [{'name': 'Mark E Cooper, MBBS, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Baker Heart Research Institute, Melbourne, Australia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Synvista Therapeutics, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Juvenile Diabetes Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Mark Cooper', 'oldOrganization': 'Baker Heart Research Institute, Melbourne, Australia'}}}}