Health Condition 1: N183- Chronic kidney disease, stage 3 (moderate)
Conditions
Interventions
Intervention1: Finerenone (BAY94-8862)
: 10 mg or 20 mg tablets once daily orally for 32 months.
Control Intervention1: Placebo: 10 mg or 20 mg placebo tablets once daily orally for 32 months.
Sponsors
Bayer Pharmaceuticals Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: A clinical diagnosis of chronic kidney disease and Urine albumin to creatinine ratio of more than equal to 200 but less than equal to 3500 mg/g and estimated glomerular filtration rate more than equal to 25 but less than 90 mL/min/1.73 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 or Angiotensin receptor blocker for at least 4 weeks prior to screening Potassium less than equal to 4.8 mmol/L at screening
Exclusion criteria
Exclusion criteria: Established diagnosis of Type 1 or 2 Diabetes mellitus or HbA1c more than equal to 6.5 percent. 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 |
|---|---|
| Mean rate of change as measured by the total slope of eGFR from baseline to Month-32Timepoint: From baseline to month 32 | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to the composite of kidney failure, sustained eGFR decline of more than equal to 57 percent, heart failure hospitalization or Cardiovascular deathTimepoint: Up to end of study visit -up to approximately 49 months;Time to the composite of kidney failure or sustained eGFR decline of more than equal to 57 percent.Timepoint: Up to end of study visit -up to approximately 49 months;Time to the composite to heart failure hospitalization or CV deathTimepoint: Up to end of study visit - up to approximately 49 months;Number of participants with Treatment-emergent adverse events Treatment-emergent serious adverse events and Adverse events of special interestTimepoint: Up to approximately 50 months | — |
Countries
Argentina, Australia, Bulgaria, China, Czech Republic, Denmark, Greece, Hong Kong, India, Israel, Italy, Japan, Malaysia, Mexico, Republic of Korea, Russian Federation, Spain, Taiwan, United States of America
Contacts
Public ContactAshish Gawde
Bayer Pharmaceuticals Private Limited
Outcome results
None listed