Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-29 @ 2:24 AM
Study NCT ID:
NCT01968668
Status:
COMPLETED
Last Update Posted:
2021-07-16
First Post:
2013-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy (ARTS-DN Japan)
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': 'C576501', 'term': 'finerenone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2014-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-15', 'studyFirstSubmitDate': '2013-10-21', 'studyFirstSubmitQcDate': '2013-10-21', 'lastUpdatePostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of urinary albumin-to creatinine ratio', 'timeFrame': 'Baseline and 90 days'}], 'secondaryOutcomes': [{'measure': 'Change in serum potassium concentration', 'timeFrame': 'Baseline and 90 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['BAY94-8862', 'MR antagonist', 'Diabetic nephropathy', 'Japanese patients'], 'conditions': ['Diabetic Nephropathies']}, 'referencesModule': {'references': [{'pmid': '31583611', 'type': 'DERIVED', 'citation': 'Snelder N, Heinig R, Drenth HJ, Joseph A, Kolkhof P, Lippert J, Garmann D, Ploeger B, Eissing T. Population Pharmacokinetic and Exposure-Response Analysis of Finerenone: Insights Based on Phase IIb Data and Simulations to Support Dose Selection for Pivotal Trials in Type 2 Diabetes with Chronic Kidney Disease. Clin Pharmacokinet. 2020 Mar;59(3):359-370. doi: 10.1007/s40262-019-00820-x.'}], 'seeAlsoLinks': [{'url': 'http://clinicaltrials.bayer.com/', 'label': 'Click here to find results for studies related to Bayer Healthcare products.'}]}, 'descriptionModule': {'briefSummary': 'This study will be conducted in Japanese subjects with type 2 diabetes mellitus and the clinical diagnosis of Diabetic Nephropathy( DN) using a multi-center, randomized, adaptive, double-blind, placebo-controlled, parallel-group design.\n\nPrimary objective of the study is investigate the change of Urinary Albumin to Creatine Ratio (UACR) after treatment with different oral doses of BAY94-8862 given once daily from baseline to Visit 8 (Day 90)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese subjects with type 2 diabetes mellitus and a clinical diagnosis of DN (Diabetic Nephropathy) treated with at least the minimal recommended dose of an Angiotensin Converting Enzyme Inhibitor (ACEI) and/or Angiotensin Receptor Blocker (ARB)\n* Subjects with a clinical diagnosis of Diabetic Nephropathy (DN) based on at least 1 of the following criteria:\n\n * Persistent very high albuminuria defined as Urinary Albumin to Creatine Ratio (UACR) of \\>/=300 mg/g (\\>/=34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) \\>/=30 mL/min/1.73 m2 but \\<90 mL/min/1.73 m2 Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) or\n * Persistent high albuminuria defined as UACR of \\>/=30 mg/g but \\<300 mg/g (\\>/=3.4 mg/mmol but \\<34 mg/mmol) in 2 out of 3 first morning void samples and eGFR\\>/=30 mL/min/1.73 m2 but \\<90 mL/min/1.73 m2 (CKD-EPI)\n* Serum potassium \\</=4.8 mmol/L at both the run-in visit and the screening visit\n\nExclusion Criteria:\n\n* Non-diabetic renal disease (confirmed by biopsy)\n* Known bilateral clinically relevant renal artery stenosis (\\>75%)\n* Glycated hemoglobin(HbA1c) \\>12% at the run-in visit or the screening visit\n* UACR \\>3000 mg/g (339 mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit\n* Hypertension with mean sitting systolic blood pressure (SBP) \\>/=180 mmHg or mean sitting diastolic blood pressure (DBP) \\>/=110 mmHg at the run-in visit or mean sitting SBP \\>/=160 mmHg or mean sitting DBP \\>/=100 mmHg at the screening visit\n* Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit\n* Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic'}, 'identificationModule': {'nctId': 'NCT01968668', 'briefTitle': 'Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy (ARTS-DN Japan)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy', 'orgStudyIdInfo': {'id': '16816'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BAY94-8862 (1.25 mg)', 'interventionNames': ['Drug: BAY94-8862']}, {'type': 'EXPERIMENTAL', 'label': 'BAY94-8862 (2.5 mg)', 'interventionNames': ['Drug: BAY94-8862']}, {'type': 'EXPERIMENTAL', 'label': 'BAY94-8862 (5 mg )', 'interventionNames': ['Drug: BAY94-8862']}, {'type': 'EXPERIMENTAL', 'label': 'BAY94-8862 (7.5 mg)', 'interventionNames': ['Drug: BAY94-8862']}, {'type': 'EXPERIMENTAL', 'label': 'BAY94-8862 (10 mg)', 'interventionNames': ['Drug: BAY94-8862']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BAY 94-8862 (15 mg)', 'interventionNames': ['Drug: BAY 94-8862']}, {'type': 'EXPERIMENTAL', 'label': 'BAY 94-8862 (20 mg)', 'interventionNames': ['Drug: BAY 94-8862']}], 'interventions': [{'name': 'BAY94-8862', 'type': 'DRUG', 'description': '1.25 mg BAY94-8862 tablet once daily in the morning', 'armGroupLabels': ['BAY94-8862 (1.25 mg)']}, {'name': 'BAY94-8862', 'type': 'DRUG', 'description': '2.5 mg BAY94-8862 tablet once daily in the morning', 'armGroupLabels': ['BAY94-8862 (2.5 mg)']}, {'name': 'BAY94-8862', 'type': 'DRUG', 'description': '5 mg BAY94-8862 tablet once daily in the morning', 'armGroupLabels': ['BAY94-8862 (5 mg )']}, {'name': 'BAY94-8862', 'type': 'DRUG', 'description': '7.5 mg BAY94-8862 tablet once daily in the morning', 'armGroupLabels': ['BAY94-8862 (7.5 mg)']}, {'name': 'BAY94-8862', 'type': 'DRUG', 'description': '10 mg BAY94-8862 tablet once daily in the morning', 'armGroupLabels': ['BAY94-8862 (10 mg)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablet once daily in the morning', 'armGroupLabels': ['Placebo']}, {'name': 'BAY 94-8862', 'type': 'DRUG', 'description': '15 mg BAY 94-8862 tablet once daily in the morning', 'armGroupLabels': ['BAY 94-8862 (15 mg)']}, {'name': 'BAY 94-8862', 'type': 'DRUG', 'description': '20 mg BAY 94-8862 tablet once daily in the morning', 'armGroupLabels': ['BAY 94-8862 (20 mg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '456-0058', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '466-0815', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '793-0027', 'city': 'Saijō', 'state': 'Ehime', 'country': 'Japan', 'geoPoint': {'lat': 33.91667, 'lon': 133.18333}}, {'zip': '830-8522', 'city': 'Kurume', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'zip': '830-8543', 'city': 'Kurume', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'zip': '080-0848', 'city': 'Obihiro', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 42.91722, 'lon': 143.20444}}, {'zip': '660-8550', 'city': 'Amagasaki', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.71667, 'lon': 135.41667}}, {'zip': '306-0232', 'city': 'Koga', 'state': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 36.18333, 'lon': 139.71667}}, {'zip': '300-0835', 'city': 'Tsuchiura', 'state': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 36.09047, 'lon': 140.21047}}, {'zip': '305-0812', 'city': 'Tsukuba', 'state': 'Ibaraki', 'country': 'Japan', 'geoPoint': {'lat': 36.08333, 'lon': 140.11667}}, {'zip': '920-0293', 'city': 'Kahoku-gun', 'state': 'Ishikawa-ken', 'country': 'Japan'}, {'zip': '762-0007', 'city': 'Sakaidechō', 'state': 'Kagawa-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.32278, 'lon': 133.8356}}, {'zip': '598-8577', 'city': 'Izumisano', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.41667, 'lon': 135.31667}}, {'zip': '581-0011', 'city': 'Yao', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.61667, 'lon': 135.6}}, {'zip': '125-0054', 'city': 'Katsushika-ku', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.73333, 'lon': 139.85}}, {'zip': '530-0001', 'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}