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

Bayer

Status and phase: Completed; Phase 3

Conditions: Diabetic Kidney Disease

Treatments: Drug: Finerenone (BAY94-8862); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02545049

17530

2015-000950-39 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study was 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.

Enrollment: 7,352 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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7,352 participants in 2 patient groups, including a placebo group

BAY94-8862

Experimental group

Description:

Finerenone tablet

Treatment:

Drug: Finerenone (BAY94-8862)

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo