Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

• Status: Completed
• Trial end date: 2021-02-02
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer

Criteria

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%