Phase 3
N=5,734
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease
Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT02540993 ↗Enrolled (actual)
5,734
Serious AEs
33.1%
Results posted
Jul 2021
Primary outcome: 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 Participants — p== 0.0014
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Finerenone (BAY94-8862) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Apr 2020
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 |
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.
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). 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.