2023-506897-11-00招募中3 期
(21177) A randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase 3 study to investigate the efficacy and safety of Finerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Bayer AG
- 入组人数
- 391
- 试验地点
- 64
- 主要终点
- Mean rate of change as measured by the total slope of eGFR from baseline to Month-32.
研究概览
简要总结
To demonstrate that finerenone in addition to Standard of Care (SoC), is superior to placebo in delaying the progression of kidney disease.
研究设计
- 分配方式
- Randomized
- 主要目的
- Overall
- 盲法
- Double (Monitor, Analyst, Carer, Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •A clinical diagnosis of chronic kidney disease and: • Urine albumin/creatinine ratio (UACR) of ≥ 200 but ≤ 3500 mg/g and estimated glomerular filtration rate (eGFR) ≥25 but <90 mL/min/1.73m^2 at screening, and • Documentation of albuminuria/proteinuria in the participant's medical records at least 3 months prior to screening.
- •Stable and maximum tolerated labeled dose of an Angiotensin converting enzyme inhibitor (ACEI) or Angiotensin receptor blocker(ARB) for at least 4 weeks prior to screening
- •K+ ≤ 4.8 mmol/L at screening
排除标准
- •Established diagnosis of Type 1 or 2 Diabetes mellitus, or HbA1c ≥ 6.5% (48 mmol/mol)
- •Autosomal dominant or autosomal recessive polycystic kidney disease
- •Lupus nephritis or anti-neutrophilic cytoplasmic autoantibody (ANCA) - associated vasculitis or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening
- •Symptomatic heart failure with reduced ejection fraction with class 1A indication for Mineralocorticoid receptor antagonist (MRA)s
结局指标
主要结局
Mean rate of change as measured by the total slope of eGFR from baseline to Month-32.
Mean rate of change as measured by the total slope of eGFR from baseline to Month-32.
次要结局
- Time to the composite of kidney failure, sustained eGFR decline of >= 57%, heart failure hospitalization or Cardiovascular (CV) death
- Time to the composite of kidney failure or sustained eGFR decline of >=57%
- Time to the composite to heart failure hospitalization or CV death
- Number of participants with Treatment-emergent adverse event (TEAE)s, Treatment-emergent serious adverse event (TESAE)s and Adverse event of special interest (AESI)
研究者
Therapeutic Area Head
Scientific
Bayer AG
研究点 (64)
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