A Parallel-group, Randomized, Prospective, Interventional, Double-blind, Multicenter Global Phase 3 Study to Investigate the Efficacy and Safety of Finerenone Versus Placebo, in Participants With Chronic Kidney Disease Not Using Renin-angiotensin-system Inhibitors
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 180
- 试验地点
- 8
- 主要终点
- Urinary albumin-to-creatinine ratio (UACR)
研究概览
简要总结
Study to demonstrate efficacy of finerenone when compared to placebo in reducing albuminuria in participants with chronic kidney disease (CKD) not using renin-angiotensin-system (RAS) inhibitors.
详细描述
FINE-START is a multicenter, international, randomized, placebo-controlled, double blind parallel-group Phase 3 study in adult participants with chronic kidney disease (CKD) not using renin-angiotensin-system (RAS) inhibitors. The study will enroll adults (≥18 years) with CKD defined as eGFR ≥25 and <120 mL/min/1.73 m2, urinary albumin-to-creatinine ratio (UACR) ≥100 mg/g (11.3 mg/mmol) to <5000 mg/g (565 mg/mmol) and documentation of elevated albuminuria or proteinuria. A total of 180 participants will be included and randomized with equal allocation (1:1) to Finerenone or placebo. Finerenone or placebo will be administered once daily for approximately 6 months. Change in UACR from baseline over 6 months will be used as a primary endpoint to demonstrate slowing of kidney disease progression. The aim of this study is to demonstrate efficacy of finerenone when compared to placebo in reducing albuminuria in participants with chronic kidney disease (CKD) not using renin-angiotensin-system (RAS) inhibitors.
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
- •Main Inclusion Criteria:
- •Adults (≥18 years) with Chronic Kidney Disease defined as:
- •eGFR ≥25 and <120 mL/min/1.73 m2 using CKD-EPI 2009 formula at the Screening visit.
- •UACR ≥100 mg/g (11.3 mg/mmol) to <5000 mg/g (565 mg/mmol) at the Screening visit (geometric mean of the 3 measurements) and documentation of elevated albuminuria or proteinuria.
- •Potassium level ≤5.0 mmol/L at Screening (local assessment).
- •No current or previous (within 8 weeks prior to the Screening visit) treatment with RAS inhibition (ACEi, ARB, or Renin inhibitor (e.g. Aliskiren)).
排除标准
- •Participants with an HbA1c>11%.
- •Participants with type 1 diabetes.
- •Symptomatic heart failure with reduced ejection fraction and class 1A indication for MRA treatment.
研究组 & 干预措施
Placebo
Placebo matching Finerenone 10mg or 20mg, tablet (oral), once daily for approximately 6 months.
干预措施: Placebo (Drug)
Finerenone
Finerenone 10mg or 20mg, tablet (oral), once daily for approximately 6 months.
干预措施: Finerenone (BAY 94-8862) (Drug)
结局指标
主要结局
Urinary albumin-to-creatinine ratio (UACR)
时间窗: Baseline upto 6 months
Change in UACR from baseline (ratio to baseline) over 6 months
次要结局
- TEAEs, TESAEs(Baseline upto 6 months)
- Number of participants with Hyperkalemia(Baseline upto 6 months)