A Phase 2b Dose-finding, Randomized, Placebo-controlled, Double-blind Study to Evaluate Efficacy and Safety of BAY 3283142 on Top of Standard of Care in Reducing Albuminuria in Patients With Chronic Kidney Disease

Description

Researchers are looking for a better way to treat people who have chronic kidney disease (CKD), CKD is a condition in which the kidneys' ability to work properly gradually decreases over time. A common sign of decreasing kidney function is the body losing too much of a protein called albumin in the urine. This condition is known as albuminuria. This can lead to a faster decline in kidney function. People who have high blood pressure and diabetes are more likely to have CKD and are at a higher risk of complications related to it. BAY3283142 is a new drug that is being developed to treat people with CKD. It works by activating a protein that helps relax blood vessels and is thought to have beneficial effects in CKD. In this study, researchers want to learn about how well different doses of BAY3283142 work when taken with standard treatment for CKD in reducing albumin in the urine of participants with CKD. They will compare the results of the change in the urine albumin-creatinine ratio

Trial Eligibility

Inclusion Criteria: * Participant must be ≥18 years of age * eGFR (Chronic Kidney Disease Epidemiology Collaboration formula) ≥20 and ≤75 mL/min /1.73 m\^2 at Screening Note: One re-assessment of eGFR based on central laboratory values is allowed during the Screening period" * UACR ≥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: * Systolic blood pressure (SBP) \<100 mmHg at Visit 2 (baseline) * Patients with a tendency for clinically relevant orthostatic hypotension at Screening and Visit 2 (baseline) as judged by the investigator * 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

Study Info

Interventions

Locations Recruiting

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