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



Status:Active, not recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Diabetes, Diabetes
Therapuetic Areas:Endocrinology, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:September 17, 2015
End Date:July 21, 2021

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A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate Efficacy and Safety of Finerenone on the Reduction of Cardiovascular Morbidity and Mortality in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease in Addition to Standard of Care.

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.


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%.
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