Phase 3
Completed N=5,734
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease
Source: ClinicalTrials.gov NCT02540993 ↗Enrolled (actual)
5,734
Serious AEs
33.1%
Results posted
Jul 2021
Primary outcomePrimary: 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 — 504; 600 Participants — p== 0.0014
◆ Published Evidence
Highly cited
2,704citations · ~451 / year
Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes.
Summary
The primary objective of this study was to demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥40% from baseline over at least 4 weeks, or renal death.
Linked Publications (5)
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Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes.
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Finerenone and Cardiovascular Outcomes in Patients With Chronic Kidney Disease and Type 2 Diabetes.
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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 Onset of Kidney Failure, a Sustained Decrease of eGFR ≥40% From Baseline Over at Least 4 Weeks, or Renal Death |
504; 600 | = 0.0014 sig |
| SECONDARY The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, or Hospitalization for Heart Failure |
367; 420 | = 0.0339 sig |
| SECONDARY All-cause Mortality |
219; 244 | = 0.2348 |
| SECONDARY All-cause Hospitalization |
1263; 1321 | = 0.1623 |
| SECONDARY Change in Urinary Albumin-to-creatinine Ratio (UACR) From Baseline to Month 4 |
0.655; 0.952 | < 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 |
252; 326 | = 0.0012 sig |
Eligibility Criteria
Inclusion Criteria
- Men or women ≥18 years of age
- Type 2 diabetes mellitus (T2D) as defined by the American Diabetes Association
- Diagnosis of chronic kidney disease (CKD) with at least one of the following criteria at run-in and screening visits:
- persistent high albuminuria (UACR ≥30 to 12%
- Mean SBP < 90 mmHg at the run-in visit or at the screening visit
- 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 antagonists [MRAs])
- Stroke, transient ischemic cerebral attack, acute coronary syndrome, or hospitalization for worsening heart failure, in the last 30 days prior to the screening visit
- Dialysis for acute renal failure within 12 weeks of run-in visit
- Renal allograft in place or scheduled within next 12 months from the run-in visit
Data sourced from ClinicalTrials.gov (NCT02540993) 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.