Trial Condition(s):
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)
16816
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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.
Primary 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)
- 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) - Subjects with a clinical diagnosis of Diabetic Nephropathy (DN) based on at least 1 of the following criteria: -- 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 -- 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) - Serum potassium </=4.8 mmol/L at both the run-in visit and the screening visit
- Non-diabetic renal disease (confirmed by biopsy) - Known bilateral clinically relevant renal artery stenosis (>75%) - Glycated hemoglobin(HbA1c) >12% at the run-in visit or the screening visit - UACR >3000 mg/g (339 mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit - 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 - 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 - Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic
Locations | |
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Locations Investigative Site Obihiro, Japan, 080-0848 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tsuchiura, Japan, 300-0835 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tsukuba, Japan, 305-0812 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Katsushika, Japan, 125-0054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kahoku-gun, Japan, 920-0293 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 466-0815 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 456-0058 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yao, Japan, 581-0011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Izumisano, Japan, 598-8577 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sakaide, Japan, 762-0007 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Saijo, Japan, 793-0027 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kurume, Japan, 830-8522 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kurume, Japan, 830-8543 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Koga, Japan, 306-0232 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 530-0001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Amagasaki, Japan, 660-8550 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
8