Non-diabetic Chronic Kidney Disease
Conditions
Interventions
- Drug: Finerenone (BAY94-8862)
Tablet, 10 mg or 20 mg, once daily (OD), oral
- Drug: Placebo
Tablet, once daily, oral
Sponsors
Myoishi Masashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A clinical diagnosis of chronic kidney disease and: Urine albumin/creatinine ratio (UACR) of >= 200 but = 25 but < 90 mL/min/1.73m2 at screening, and Documentation of albuminuria/proteinuria in the participant's medical records at least 3 months prior to screening. Stable and maximum tolerated labeled dose of an Angiotensin-converting enzyme inhibitor (ACEI) or Angiotensin receptor blocker (ARB) for at least 4 weeks prior to screening K+ <=4.8 mmol/L at screening
Exclusion criteria
Exclusion criteria: Established diagnosis of Type 1 or 2 Diabetes mellitus, or HbA1c >= 6.5% (48 mmol/mol) Autosomal dominant or autosomal recessive polycystic kidney disease Lupus nephritis or anti-neutrophilic cytoplasmic autoantibody (ANCA) -associated vasculitis or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening Symptomatic heart failure with reduced ejection fraction with class 1A indication for Mineralocorticoid receptor antagonists (MRAs)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean rate of change as measured by the total slope of eGFR from baseline to Month-32. [ Time Frame: From baseline to month 32 ] eGFR: Estimated glomerular filtration rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to the composite of kidney failure, sustained eGFR decline of >= 57%, heart failure hospitalization or Cardiovascular (CV) death [ Time Frame: Up to end of study visit (up to approximately 49 months) ] 2. Time to the composite of kidney failure or sustained eGFR decline of >= 57% [ Time Frame: Up to end of study visit (up to approximately 49 months) ] 3. Time to the composite to heart failure hospitalization or CV death [ Time Frame: Up to end of study visit (up to approximately 49 months) ] 4. Number of participants with Treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse events (TESAEs) and Adverse events of special interest (AESI) [ Time Frame: Up to approximately 50 months ] | — |
Countries
Argentina, Australia, Belgium, Bulgaria, China, Czechia, Denmark, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Malaysia, Mexico, Portugal, Russian Federation, Singapore, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactDedicated contact
Bayer Yakuhin, Ltd.
Outcome results
None listed