Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-29 @ 10:59 AM
Study NCT ID:
NCT01094769
Status:
COMPLETED
Last Update Posted:
2023-09-14
First Post:
2010-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}], 'ancestors': [{'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'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C043482', 'term': 'moxonidine'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2020-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-13', 'studyFirstSubmitDate': '2010-03-26', 'studyFirstSubmitQcDate': '2010-03-26', 'lastUpdatePostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urine albumin/creatinine ratio (UACR)', 'timeFrame': '12 weeks', 'description': 'The primary outcome measure is the difference in the change of UACR between active treatment and placebo from baseline to week 12 of treatment.'}], 'secondaryOutcomes': [{'measure': 'muscle sympathetic nerve activity (MSNA)', 'timeFrame': '12 weeks', 'description': 'Secondary outcome measure is the difference between active and placebo treatment in the change from baseline to week 12 of treatment in muscle sympathetic nerve activity'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetic Nephropathies']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether moxonidine is effective in reducing urine albumin levels in patients with diabetic kidney disease.', 'detailedDescription': 'This study will investigate the effect of moxonidine in lowering urine albumin excretion and limiting further damage to the kidneys in patients with diabetic nephropathy. Reducing urine albumin excretion in type 2 diabetic patients is an indicator of successful treatment. Previous studies have shown that drugs that work in a similar fashion to moxonidine (intervene with the sympathetic nervous system)have been very effective in reducing the amount of albumin in the urine and are associated with long term renal and cardiovascular protection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 18-75 years\n* diabetic nephropathy as defined by the mean of three consecutive early morning urinary albumin-creatinine ratios (UACR) of \\>300mg per gram, or \\> 200mg per gram in patients receiving therapy targeted at blockade of the RAS\n\nExclusion Criteria:\n\n* non-diabetic kidney disease\n* UACR of more than 3500mg per gram, an estimated glomerular filtration rate of less than 30ml/min/1.73m2.\n* chronic urinary tract infection.\n* severe hypertension\n* heart failure New York Heart Association (NYHA) class II-IV\n* major cardiovascular disease within the previous 6 months\n* left ventricular ejection fraction \\<55%'}, 'identificationModule': {'nctId': 'NCT01094769', 'briefTitle': 'Sympathetic Nervous System Inhibition for the Treatment of Diabetic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Baker Heart and Diabetes Institute'}, 'officialTitle': 'Sympathetic Nervous System Inhibition for the Treatment of Diabetic Nephropathy', 'orgStudyIdInfo': {'id': '101/10'}, 'secondaryIdInfos': [{'id': '58667', 'type': 'OTHER_GRANT', 'domain': 'NHMRC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moxonidine', 'interventionNames': ['Drug: Moxonidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Moxonidine', 'type': 'DRUG', 'otherNames': ['Physiotens'], 'description': 'Patients will receive moxonidine treatment for 12 weeks, at a dose of 0.4mg/d for the first 6 weeks of treatment followed by up-titration of the dose to 0.6 mg/d for the final 6 weeks.', 'armGroupLabels': ['Moxonidine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['sugar pill'], 'description': 'lactose capsule taken once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred & Baker Medical Unit', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Markus P Schlaich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baker Heart and Diabetes Institute'}, {'name': 'Gavin W Lambert, BSc PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baker Heart and Diabetes Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baker Heart and Diabetes Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}