A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of GDC-8264 in Preventing Cardiac Surgery-Associated Acute Kidney Injury and Major Adverse Kidney Events
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 67
- 试验地点
- 69
- 主要终点
- Percentage of Participants who Develop MAKE90
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of GDC-8264 compared with placebo in participants undergoing cardiac surgery who are determined to be at moderate to high risk of developing AKI and subsequent MAKE at 90 days after surgery (MAKE90). The study will be performed in two parts- Part 1 and Part 2.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •One of the following non-emergent cardiac surgery types that requires cardiopulmonary bypass (CPB) to be done in one procedure rather than separate procedures: Isolated Coronary Artery Bypass Grafting (CABG); Isolated Surgical Aortic Valve Replacement (AVR), Mitral Valve Replacement (MVR), Mitral Valve repair (MVr); Combined CABG+AVR, CABG+MVR, CABG+MVr, AVR+MVR, AVR+MVr
- •At least one or at least two of the following AKI risk factors, depending on the type of surgery: age > 70 years, history of CKD with eGFR < 60 milliliters/ minutes/ 1.73 meter square (ml/min/1.73 m^2) within the last 6 months, diabetes (type 1 or type 2) requiring at least one oral hypoglycemic agent or insulin, history of chronic obstructive pulmonary disease (COPD) requiring medical therapy, left ventricular ejection fraction (LVEF) < 40%, preoperative anemia [hemoglobin <10 grams/deciliters (g/dL)]
- •Stable kidney function with no known episodes of AKI within 2 weeks of screening
排除标准
- •Need for renal replacement therapy (peritoneal dialysis or hemodialysis)
- •Need for intra-aortic balloon pump, temporary mechanical circulatory support, or extracorporeal membrane oxygenation prior to scheduled surgery
- •Presence of a durable left ventricular assist device
- •Need for concurrent aortic surgery that requires circulatory arrest and deep hypothermia or repair of congenital heart defects
- •Heart transplant
- •Transcatheter valve replacements
- •Hypotension or shock requiring hospital admission
- •Cardiopulmonary resuscitation
- •eGFR < 20 mL/min/1.73 m^2
- •Heart failure with ejection fraction < 20%, or episode of decompensated heart failure requiring intervention within 2 weeks prior to screening
- •History of kidney transplant or only one kidney (due to donation)
- •Renal agenesis, total nephrectomy, or partial nephrectomy of > 50%
研究组 & 干预措施
Part 1: GDC-8264
Participants will receive GDC-8264 as per a pre-defined dosing regimen in Part 1.
干预措施: GDC-8264 (Drug)
Part 1: Placebo
Participants will receive GDC-8264 matching placebo as per a pre-defined dosing regimen in Part 1.
干预措施: Placebo (Drug)
Part 2: GDC-8264
Participants will receive GDC-8264 as per a pre-defined dosing regimen in Part 2.
干预措施: GDC-8264 (Drug)
Part 2: Placebo
Participants will receive GDC-8264 matching placebo as per a pre-defined dosing regimen in Part 1.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants who Develop MAKE90
时间窗: From Day 0 (day of surgery) up to Day 90 post-surgery
Number of Participants With Adverse Events (AEs)
时间窗: Up to Day 90 post surgery
次要结局
- Percentage of Participants who Develop AKI(From Day 0 (day of surgery) up to Day 7 post surgery)
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)(Baseline up to Days 30, 60 and 90 post surgery)
- Number of Participants With New or Worsened Chronic Kidney Disease (CKD)(Baseline up to Day 90 post surgery)
- Percentage of Participants who Develop MAKE30 and MAKE60(From Day 0 (day of surgery) to Day 30, Day 60 post surgery)