Chronic kidney disease
Conditions
Interventions
Placebo Comparator: Arm 1
Placebo OD and sham titration after 14 days and after 28 days
Experimental: Arm 2
BAY3283142 (dose 1) OD and sham titration after 14 days and after 28 days
Experimental: Arm
Sponsors
Myoishi Masashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participant must be >=18 years of age - eGFR (CKD-EPI formula) >=20 and ==200 mg/g and<3500 mg/g as determined by the geometric mean (as calculated by the central laboratory) of 3 morning void urine specimens obtained at Screening - Treatment with the highest tolerated labeled dose of either angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blockers (ARB), unless such treatment is either not tolerated or contraindicated. Treatment dose must be stable dose for at least 4 weeks before Screening with no planned change of the therapy during the study - If the participant receives any of the following treatments it should be stable for 4 weeks prior to Screening: sodium-glucose co-transporter-2 (SGLT2) inhibitor, finerenone, diuretics, endothelin-receptor antagonists, or glucagon-like peptide (GLP) receptor agonist
Exclusion criteria
Exclusion criteria: - Systolic blood pressure (SBP) =160 mmHg, unless treated with >=3 blood pressure lowering medications, at Screening or at Visit 2 (baseline) - History of secondary hypertension other than CKD - Hepatic impairment corresponding to Child-Pugh B or C or other significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis as indicated by e.g. AST or ALT >3x ULN or total bilirubin >2x ULN) at Screening - Polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis and any other kidney disease requiring immunosuppressive therapy within 6 months prior to Screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 16 in the logarithm of urine albumin-creatinine ratio (UACR) [ Time Frame: From baseline to Week 16 ] | — |
Countries
Argentina, Belgium, China, Greece, India, Italy, Japan, Portugal, Singapore, Slovakia, Spain, Sweeden, Taiwan, United Kingdom, United State
Contacts
Public Contactcontact Dedicated
Bayer Yakuhin, Ltd.
Outcome results
None listed