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
概览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer Pharmaceuticals Private Limited
- 入组人数
- 1,400
- 试验地点
- 6
- 主要终点
- The primary efficacy objective is to estimate and assess a dose-response relationship in the primary endpoint of mean change in UACR from baseline after 16 weeks of treatment with BAY 3283142 compared with placebo in addition to SoC in CKD patients
概览
简要总结
Chronic Kidney Disease (CKD) impacts 10% to 12% of the global population and it is a progressive condition, with albuminuria as important risk factor for a more rapid decline in kidney function.
Prevention of kidney disease progression and decrease in cardiovascular risk will remain an unmet clinical need among patients with CKD requiring new treatments with agents targeting new mechanisms of action.
BAY 3283142 is a soluble guanylate cyclase (sGC) activator under development for treatment of CKD to reduce proteinuria and improve cardiovascular and renal outcomes of patients.
It is anticipated that activation of sGC by BAY 3283142 under conditions of oxidative stress that are prevailing in CKD, will reduce CV mortality and progression of kidney disease in patients suffering from CKD by reducing intraglomerular filtration pressure, albuminuria, and kidney fibrosis.
The primary objective of this study is to estimate and assess a dose-response relationship of BAY 3283142 (2.5 mg, 5 mg, 10 mg, 15 mg or 20 mg Once Daily) compared with placebo in the primary endpoint of mean change from baseline in Urine albumin-creatinine ratio (UACR) at Week 16 in CKD patients, with or without diabetes, treated on top of SoC including RAS inhibitor, SGLT2 inhibitor and/or finerenone. This study will support dose selection for the planned Phase 3 study in CKD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants aged ≥18 years, male or female (not of child-bearing potential)
- •CKD patients with eGFR more than or equal 20 and less than or 75 ml/min/1.73 m² and UACR more than or equal 200 mg/g and less than 3000 mg/g at screening visit.
排除标准
- •Hepatic impairment (AST or ALT more than 3x the ULN; or total bilirubin more than 2x ULN) at Screening
- •Stroke, TIA, ACS, or hospitalization for worsening heart failure in the last 3 months prior to 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
- •SBP less than 100 mmHg at Visit 2 (baseline).
结局指标
主要结局
The primary efficacy objective is to estimate and assess a dose-response relationship in the primary endpoint of mean change in UACR from baseline after 16 weeks of treatment with BAY 3283142 compared with placebo in addition to SoC in CKD patients
时间窗: Up to 24 weeks
次要结局
- Efficacy - • To investigate the course of eGFR over time(• To investigate the mean change from baseline in UACR over time.)
研究者
Aleksandr Poskonnyi
Bayer Pharmaceuticals Private Limited