A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for Acute Kidney Injury (AKI) Following Cardiac Surgery
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 1,043
- 试验地点
- 104
- 主要终点
- Proportion of subjects through day 90 who develop major adverse kidney events
研究概览
简要总结
This trial is designed to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events (MAKE) in subjects at high risk for acute kidney injury following cardiac surgery. Half of the participants will receive QPI-1002 while the other half will receive placebo.
详细描述
This is a randomized, double-blind, placebo-controlled, Phase 3 trial to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events in subjects at high risk for acute kidney injury following cardiac surgery. Subjects will be dosed with active drug or placebo after the completion of cardiovascular surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female, age ≥ 18 years old
- •At risk for AKI following cardiac surgery on the basis of at least one of the following pre-operatively assessed risk factors:
- •Reduced renal function
- •Diabetes with ongoing insulin treatment
- •Albuminuria
- •Undergoes non-emergent open chest cavity cardiovascular surgeries, with use of cardiopulmonary bypass (CPB), with or without hypothermic circulatory arrest
排除标准
- •Emergent surgeries, including aortic dissection, and major congenital heart defects
- •Undergoes cardiac surgery off CPB for subjects ≥45 years old. (Cardiac surgery off CPB for subjects <45 years old is allowed.)
- •Perioperative or post cardiac surgery, an left ventricular assist device (LVAD) is inserted or anticipated
研究组 & 干预措施
QPI-1002
QPI-1002 Injection, Single dose
干预措施: teprasiran (Drug)
Placebo
isotonic saline
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects through day 90 who develop major adverse kidney events
时间窗: Baseline through day 90
次要结局
- Proportion of subjects who die or initiate dialysis through day 90(Baseline through day 90)
- Proportion of subjects developing AKI overall by modified AKIN criteria within 5 days post-surgery(Baseline through day 5)
- Renal function as estimated by glomerular filtration rate(Baseline through Day 90)