Safety and efficacy of BAY 3283142 in patients with chronic kidney disease

JRCT ID: jRCT2031240249

Registered date:01/08/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic kidney disease
• Date of first enrollment: 29/08/2024
• Target sample size: 700
• Countries of recruitment: Sweeden,Japan,Belgium,Japan,Italy,Japan,Greece,Japan,Portugal,Japan,United Kingdom,Japan,Slovakia,Japan,Spain,Japan,Singapore,Japan,India,Japan,China,Japan,Argentina,Japan,United State,Japan,Taiwan,Japan
• Study type: Interventional

Intervention(s)

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 3
BAY3283142 (dose 2) OD and sham titration after 14 days and after 28 days
Experimental: Arm 4
BAY3283142 (dose 2) OD and uptitration to dose 3 OD after 14 days and sham titration after 28 days
Experimental: Arm 5
BAY3283142 (dose 2) OD and uptitration to dose 3 OD after 14 days and to dose 4 OD after 28 days
Experimental: Arm 6
BAY3283142 (dose 3) OD and uptitration to dose 5 OD after 14 days and sham titration after 28 days

Outcome(s)

• Primary Outcome: Change from baseline to Week 16 in the logarithm of urine albumin-creatinine ratio (UACR) [ Time Frame: From baseline to Week 16 ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Participant must be >=18 years of age
- eGFR (CKD-EPI formula) >=20 and =<75 mL/min /1.73 m2 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

Exclude 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

Related Information

• Primary Sponsor: Myoishi Masashi
• Secondary ID(s): NCT06522997