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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,584
- 试验地点
- 612
- 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
Researchers are looking for a better way to treat people who have non-diabetic chronic kidney disease (non-diabetic CKD). The trial treatment, finerenone, is being developed to help people who have long lasting kidney disease, also known as chronic kidney disease (CKD). It works by blocking a certain hormone called aldosterone that causes injury and inflammation in the heart and kidney which is known to play a role in CKD.
In this trial, the researchers want to learn if finerenone helps to slow down the worsening of the participants' non-diabetic CKD compared to a placebo. A placebo looks like a trial treatment but does not have any medicine in it. The trial will include about 1,580 men and women who are at least 18 years old.
The participants will take finerenone or a placebo once a day as tablets by mouth. All of the participants will also continue to take their current medicine for their CKD. The participants will be in the trial for up to about 50 months.
During the trial, the doctors will collect blood and urine samples and check the participants' health. The participants will also answer questions about how they are feeling and what adverse events they are having. An adverse event is a medical problem that happens during the trial. Doctors keep track of all adverse events that happen in trials, even if they do not think the adverse events might be related to the trial treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 antagonists (MRAs)
研究组 & 干预措施
Finerenone (BAY94-8862)
Participants will receive finerenone.
干预措施: Finerenone (BAY94-8862) (Drug)
Placebo
Participants will receive placebo.
干预措施: Placebo (Drug)
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.
时间窗: From baseline to month 32
eGFR: Estimated glomerular filtration rate
次要结局
- Time to the composite of kidney failure, sustained eGFR decline of >= 57%, heart failure hospitalization or Cardiovascular (CV) death(Up to end of study visit (up to approximately 49 months))
- Time to the composite of kidney failure or sustained eGFR decline of >= 57%(Up to end of study visit (up to approximately 49 months))
- Time to the composite to heart failure hospitalization or CV death(Up to end of study visit (up to approximately 49 months))
- Number of participants with Treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse events (TESAEs) and Adverse events of special interest (AESI)(Up to approximately 50 months)