Lead Sponsor

Bayer

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•Men or women ≥18 years of age
•Subjects with Type Type 2 Diabetes Mellitus as defined by the American Diabetes Association
•Diagnosis of Diabetic Kidney Disease with persistent high albuminuria or persistent very high albuminuria at the Run-In and Screening Visit
•Pretreated with either angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at maximal tolerated labeled dose without adjustments
•Serum potassium \<=4.8 mmol/L

•Confirmed significant non-diabetic renal disease, including clinically relevant renal artery stenosis
•Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP) ≥170 mmHg or mean sitting diastolic blood pressure(DBP) ≥110 mmHg at run in visit, or mean sitting SBP ≥160 mmHg or mean sitting DBP ≥100 mmHg at screening)
•Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms {New York Heart Association (NYHA) class II - IV} at Run in visit \[class 1A recommendation for mineralcorticoid receptor antagonist (MRAs)\]
•Dialysis for acute renal failure within 12 weeks of Run-in visit
•Renal allograft in place or scheduled kidney transplant within next 12 months
•Glycated hemoglobin (HbA1c) \>12%