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

Phase 3

Completed

• Conditions: Diabetic Kidney Disease
• Interventions: Drug: Finerenone (BAY94-8862); Drug: Placebo

• Registration Number: NCT02545049
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-07
• Study First Posted: 2015-09-09
• Study Start: 2015-09-17
• Primary Completion: 2021-02-02
• Study Completion: 2021-02-02
• Results First Submitted: 2022-01-25
• Status Verified: 2022-04
• Results First Submitted QC: 2022-04-13
• Last Update Submitted: 2022-04-13
• Results First Posted: 2022-04-15
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7352

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BAY94-8862	Finerenone (BAY94-8862)	Finerenone tablet
Placebo	Placebo	Matching placebo

Primary Outcome Measures

Name	Time	Method
The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non Fatal Stroke, or Hospitalization for Heart Failure.	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.	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.

Secondary Outcome Measures

Name	Time	Method
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.	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.	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.
All-cause Hospitalization	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	Number of participants with first occurrence of a hospitalization event were reported as descriptive result.
All-cause Mortality	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	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.
Change in Urinary Albumin-to-creatine Ratio (UCAR) From Baseline to Month 4	From baseline up until 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.
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	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	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.