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)

Bayer Yakuhin, Ltd.0 个研究点目标入组 700 人开始时间: 2024年8月29日最近更新: 2024年9月18日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方: Bayer Yakuhin, Ltd.
入组人数: 700
主要终点: Change from baseline to Week 16 in the logarithm of urine albumin-creatinine ratio (UACR)

暂无简介。

•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

Change from baseline to Week 16 in the logarithm of urine albumin-creatinine ratio (UACR)

时间窗: From baseline to Week 16

Change from baseline to Week 16 in the logarithm of urine albumin-creatinine ratio (UACR)

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发起方