Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT01935167
Status:
COMPLETED
Last Update Posted:
2017-02-17
First Post:
2013-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Determine the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-16', 'studyFirstSubmitDate': '2013-08-30', 'studyFirstSubmitQcDate': '2013-09-03', 'lastUpdatePostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'log ACR', 'timeFrame': '24 weeks after 1st administration', 'description': 'logarithm of the Albumin Creatinine Ratio(ACR) after 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Log UAE', 'timeFrame': '24 weeks after 1st administration', 'description': 'Urinary Albumin Excretion(UAE) after 12 and 24 weeks'}, {'measure': 'eGFR', 'timeFrame': '12 and 24 weeks after 1st administration', 'description': 'estimated Glomerular Filtration Rate(eGFR) after 12 and 24 weeks'}, {'measure': 'log ACR', 'timeFrame': '12 weeks after 1st administration', 'description': 'logarithm of the Albumin Creatinine Ratio(ACR) after 12 weeks'}, {'measure': 'SCC', 'timeFrame': '12 and 24 weeks after 1st administration', 'description': 'Serum Creatinine Concentration(SCC) after 12 and 24 weeks'}, {'measure': 'Cystatin C', 'timeFrame': '12 and 24 weeks after 1st administration', 'description': 'Cystatin C after 12 and 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Microalbuminuria'], 'conditions': ['Diabetic Nephropathy']}, 'descriptionModule': {'briefSummary': 'Phase 2 clinical study to evaluate of the efficacy and safety of DW1029M on microalbuminuria in Patients With Diabetic Nephropathy', 'detailedDescription': 'A Phase Ⅱ, prospective, 24 weeks, double-blind, placebo-controlled, randomized, multi-center clinical trial for the evaluation of the efficacy and safety of DW1029M on microalbuminuria in Patients With Diabetic Nephropathy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has confirmed diabetic mellitus prior to 6years\n* Has confirmed microalbuminuria 30 \\~ 299㎍/㎎creatinine prior to 5months one time and microalbuminuria 30 \\~ 299㎍/㎎creatinine during screening period\n* Blood Pressure(BP) ≤ 150 / 90 mmHg\n* estimated glomerular filtration rate(eGFR) ≥ 30 ml/min/1.73m2\n* Hemoglobin A1c(HbA1c) ≤ 9%\n* Low density lipoprotein(LDL-C) ≤ 130mg/dl\n\nExclusion Criteria:\n\n* kidney or liver disease as follows i.Serum Creatinine \\> 2.0mg/dl ii.Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) \\> 2 x Upper Limit Normal(ULN) iii.Total Bilirubin \\> 2 x ULN\n* Organic gastrointestinal disorder or Chronic gastroenterologic disorders prior to 6 months as follows \\[NOTE\\] Active Crohn's disease, Active ulcerative colitis, Chronic peptic ulcer disease, etc.\n* cardiovascular disease prior to 3 months as follows \\[NOTE\\] Unstable angina pectoris, Myocardial infarction, Coronary artery bypass surgery, Percutaneous Transluminal Coronary Angioplasty, transient ischemic attack, cerebrovascular accident etc."}, 'identificationModule': {'nctId': 'NCT01935167', 'briefTitle': 'To Determine the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong Wha Pharmaceutical Co. Ltd.'}, 'officialTitle': 'A Phase Ⅱ, Prospective, 24 Weeks, Double-blind, Placebo-controlled, Randomized, Multi-center Clinical Trial for the Evaluation of the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy', 'orgStudyIdInfo': {'id': 'DW1029M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A Group', 'description': 'DW1029M 600mg for 24 weeks', 'interventionNames': ['Drug: DW1029M 600mg']}, {'type': 'EXPERIMENTAL', 'label': 'B Group', 'description': 'DW1029M 1200mg for 24 weeks', 'interventionNames': ['Drug: DW1029M 1200mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C Group', 'description': 'Placebo for 24 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'DW1029M 600mg', 'type': 'DRUG', 'otherNames': ['DW1029M 150mg 2 tablets'], 'description': 'DW1029M 150mg 2 tablets b.i.d', 'armGroupLabels': ['A Group']}, {'name': 'DW1029M 1200mg', 'type': 'DRUG', 'otherNames': ['DW1029M 300mg 4 tablets'], 'description': 'DW1029M 300mg 2 tablets b.i.d', 'armGroupLabels': ['B Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo 2 tablets b.i.d.', 'armGroupLabels': ['C Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100-130', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'DongWha Pharm', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'MoonKyu Lee, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong Wha Pharmaceutical Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}