Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease (FIGARO-DKD)

This is an interventional treatment trial for Diabetic Kidney Disease focused on measuring Type 2 Diabetes, Kidney diseases Read More

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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%