2024-513125-23-00已完成2 期
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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 18
- 主要终点
- 1. Proportion of patients who develop MAKE90 defined as the occurrence of any of the following within 90 days after surgery: – Death – Requirement for dialysis – ≥ 25% decline in eGFR from baseline to Day 90 after surgery
研究概览
简要总结
To evaluate the efficacy of GDC-8264 compared with placebo with respect to proportion of patients who develop major adverse kidney events at 90 days after surgery (MAKE90) To evaluate the safety of GDC-8264 compared with placebo
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age > 40 years at time of signing Informed Consent Form
- •One of the listed 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), or mitral valve repair (MVr) - Combined CABG+AVR, CABG+MVR, CABG+MVr, AVR+MVR, or AVR+MVr Tricuspid annuloplasty at the time of mitral valve surgery, if deemed necessary by the investigator, would not preclude the patient from participating in this study
- •At least one or at least two of the following AKI risk factors Age > 70 years A history of CKD with eGFR < 60 mL/min/1.73m2 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 g/dL)
- •Stable kidney function as determined by the investigator with no known episodes of AKI within 2 weeks of screening
- •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
- •For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
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 (patent foramen ovale and bicuspid aortic valve are not exclusions)
- •Heart transplant
- •Hypotension or shock requiring hospital admission
研究组 & 干预措施
GDC-8264, GDC-8264, GDC-8264
Test
干预措施: GDC-8264 (Drug)
Placebo: GDC-8264
Placebo
干预措施: Placebo: GDC-8264 (Drug)
结局指标
主要结局
1. Proportion of patients who develop MAKE90 defined as the occurrence of any of the following within 90 days after surgery: – Death – Requirement for dialysis – ≥ 25% decline in eGFR from baseline to Day 90 after surgery
1. Proportion of patients who develop MAKE90 defined as the occurrence of any of the following within 90 days after surgery: – Death – Requirement for dialysis – ≥ 25% decline in eGFR from baseline to Day 90 after surgery
次要结局
- 1. Proportion of patients who develop AKI, defined by the Kidney Disease Improving Global Outcomes (KDIGO) criteria within 7 days after surgery
- 2. Change in eGFR from baseline to POD 30, 60, and 90
- 3. Incidence of new CKD at POD 90 or worsened baseline CKD by Grade 1 or more within 90 days after surgery, including from Stage 3a to 3b
- 4. Proportion of patients who develop MAKE30 (within 30 days after surgery) and MAKE60 (within 60 days after surgery), defined as the occurrence of any of the following: – Death – Requirement for dialysis – ≥ 25% decline in eGFR from baseline to Day 30 and Day 60 after surgery
研究者
US Program Manager Product Development Regulatory
Scientific
Genentech Inc.
研究点 (18)
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