Phase 3
Completed N=7,437
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
Diabetic Kidney Disease
Source: ClinicalTrials.gov NCT02545049 ↗
Enrolled (actual)
7,437
Serious AEs
32.3%
Results posted
Apr 2022
Primary outcomePrimary: The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non Fatal Stroke, or Hospitalization for Heart Failure. — 458; 519 Participants — p=0.0264
◆ Published Evidence
Highly cited
1,555citations · ~311 / year
Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes.
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.
Linked Publications (5)
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Cardiovascular Events with Finerenone in Kidney Disease and Type 2 Diabetes.
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Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial.
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Finerenone Across Cardiovascular-Kidney-Metabolic Syndrome Stages: Post Hoc Analysis of the FIDELITY Randomized Clinical Trials.
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An integrative framework for drug target discovery bridging clinical trial and genetic data insights.
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Finerenone increases the likelihood of improved KDIGO risk category in patients with CKD and type 2 diabetes: An analysis from FIDELITY.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non Fatal Stroke, or Hospitalization for Heart Failure. |
458; 519 | 0.0264 sig |
| SECONDARY 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. |
350; 395 | 0.0689 |
| SECONDARY All-cause Hospitalization |
1573; 1605 | 0.3558 |
| SECONDARY All-cause Mortality |
333; 370 | 0.1337 |
| SECONDARY Change in Urinary Albumin-to-creatine Ratio (UCAR) From Baseline to Month 4 |
0.624; 0.922 | <0.0001 sig |
| SECONDARY 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 |
108; 139 | 0.0406 sig |
Eligibility 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 12%
Data sourced from ClinicalTrials.gov (NCT02545049) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.