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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Diabetic Kidney Disease

Intervention / Treatment
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* Drug: Finerenone (BAY94-8862)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY94-8862<br>Finerenone tablet | Drug: Finerenone (BAY94-8862)<br>* 10 mg or 20 mg Finerenone tablet to be given orally, once daily.<br>|
| Placebo Comparator: Placebo<br>Matching placebo | Drug: Placebo<br>* Matching placebo to be taken orally, once daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non Fatal Stroke, or Hospitalization for Heart Failure. | Number of participants with the first occurrence of the primary cardiovascular (CV) composite outcome, CV death, non-fatal myocardial infarction (MI), non-fatal stroke, or hospitalization for heart failure were reported as descriptive result. | From randomization up until the first occurrence of the CV composite endpoint, or censoring at the end of the study, with an average study duration of 41 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease of eGFR ≥40% From Baseline Over at Least 4 Weeks, or Renal Death. | Number of participants with first occurrence of the composite endpoint of onset of kidney failure, a sustained decrease of eGFR ≥40% from baseline over at least 4 weeks, or renal death were reported as descriptive result. | From randomization up until the first occurrence of the renal composite endpoint, or censoring at the end of the study, with an average study duration of 41 months. | 
| All-cause Hospitalization | Number of participants with first occurrence of a hospitalization event were reported as descriptive result. | From randomization up until the first occurrence of the hospitalization due to any cause, or censoring at the end of study, with an average study duration of 41 months | 
| All-cause Mortality | Number of participants with death due to any cause were reported as descriptive result. Number of participants with outcome death reported here includes deaths occurred after randomization until the end of the study visit. Deaths after end of study visit are not included in this table. | From randomization up until death due to any cause, or censoring at the end of the study, with an average study duration of 41 months | 
| Change in Urinary Albumin-to-creatine Ratio (UCAR) From Baseline to Month 4 | First morning void urine samples were collected to evaluate the urinary albumin-to-creatinine ratio (UACR). Month 4 was the visit closest to day 120 within a time window of 120 ± 30 days after randomization. If no measurements were available in this time window, the participant was excluded from this analysis. Ratio of UACR at Month 4 to UACR at baseline is reported as the change. | From baseline up until Month 4 | 
| The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease in eGFR of ≥57% From Baseline Over at Least 4 Weeks, or Renal Death | Number of participants with first occurrence of the renal composite outcome, onset of kidney failure, a sustained decrease in eGFR of ≥57% from baseline over at least 4 weeks, or renal death were reported as descriptive result. | From randomization up until the first occurrence of the renal composite endpoint, or censoring at the end of the study, with an average study duration of 41 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney diseases, Type 2 Diabetes