臨床研究等提出・公開システム

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 (ALPINE 1)

Safety and efficacy of BAY 3283142 in patients with chronic kidney disease (ALPINE 1)

Myoishi Masashi

Bayer Yakuhin, Ltd.

2-4-9 Umeda, Kita-ku, Osaka, Osaka

byl_ct_contact@bayer.com

Dedicated contact

Bayer Yakuhin, Ltd.

2-4-9 Umeda, Kita-ku, Osaka, Osaka

+81-6-6133-6363

byl_ct_contact@bayer.com

Not Recruiting

Aug. 30, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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

- 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

Both

Chronic kidney disease

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

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

+81-3-5213-0028

July. 05, 2024

No

Sweeden/Belgium/Italy/Greece/Portugal/United Kingdom/Slovakia/Spain/Singapore/India/China/Argentina/United State/Taiwan