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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)","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","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\u002For 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 \\>\u002F=300 mg\u002Fg (\\>\u002F=34 mg\u002Fmmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) \\>\u002F=30 mL\u002Fmin\u002F1.73 m2 but \\\u003C90 mL\u002Fmin\u002F1.73 m2 Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) or\n  * Persistent high albuminuria defined as UACR of \\>\u002F=30 mg\u002Fg but \\\u003C300 mg\u002Fg (\\>\u002F=3.4 mg\u002Fmmol but \\\u003C34 mg\u002Fmmol) in 2 out of 3 first morning void samples and eGFR\\>\u002F=30 mL\u002Fmin\u002F1.73 m2 but \\\u003C90 mL\u002Fmin\u002F1.73 m2 (CKD-EPI)\n* Serum potassium \\\u003C\u002F=4.8 mmol\u002FL 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\u002Fg (339 mg\u002Fmmol) 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) \\>\u002F=180 mmHg or mean sitting diastolic blood pressure (DBP) \\>\u002F=110 mmHg at the run-in visit or mean sitting SBP \\>\u002F=160 mmHg or mean sitting DBP \\>\u002F=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","ALL","18 Years",{"count":212,"type":213},96,"ACTUAL","INTERVENTIONAL",[216],"PHASE2","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)",[219],"Diabetic Nephropathies",[41,221,222,223],"MR antagonist","Diabetic nephropathy","Japanese patients","COMPLETED","2021-07-15",{"date":227,"type":213},"2021-07-16",{"date":229,"type":213},"2013-10-28",{"date":231,"type":213},"2014-11-07",{"name":5,"class":6},16]