NCT05746559终止3 期
ARTEMIS: RAvulizumab to PRotect PaTients With Chronic Kidney DisEase (CKD) froM Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and Subsequent Major Adverse Kidney Events (MAKE): A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 555
- 试验地点
- 131
- 主要终点
- Number of Participants Experiencing Major Adverse Kidney Events (MAKE) (Based on serum Cystatin C [sCysC]) at Day 90 Post Cardiopulmonary Bypass (CPB)
研究概览
简要总结
The primary objective of this study is to assess the efficacy of a single dose of ravulizumab IV compared with placebo in reducing the risk of the clinical consequences of AKI (MAKE) at 90 days in adult participants with CKD who undergo non-emergent cardiac surgery with CPB.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant weighs ≥ 30 kg
- •Planned non-emergent sternotomy with CPB procedure for the following surgeries:
- •Multi-vessel CABG
- •Valve replacement or repair; ascending aorta surgery permitted if combined with aortic valve replacement/repair
- •Combined CABG and valve surgery; inclusion of single-vessel CABG when combined with valve replacement/repair is permitted
- •Known CKD for at least 90 days (CKD Stage 3A, 3B, or 4)
排除标准
- •Emergency or salvage cardiac surgery is expected at screening or randomization, as assessed by the investigator.
- •Single-vessel CABG without valve surgery is planned.
- •Off-pump surgery is planned (eg, surgery without CPB).
- •Recipient of a solid organ or bone marrow transplantation.
- •Cardiogenic shock, hemodynamic instability, use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device within 72 hours of randomization.
- •Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.
- •History of unexplained, recurrent infection.
- •Any use of KRT or presence of AKI within 30 days of randomization
- •Use of any complement inhibitors, or plasmapheresis or plasma exchange within the year prior to Screening, or planned use during the course of the study.
- •Participant is not willing to be vaccinated against N meningitidis or is unwilling to receive prophylactic treatment with appropriate antibiotics , if needed
- •History of or unresolved N meningitidis infection.
研究组 & 干预措施
Ravulizumab
Experimental
Participants will receive a single weight-based dose of ravulizumab, via intravenous infusion, 1 to 7 days prior to surgery.
干预措施: Ravulizumab (Drug)
Placebo
Placebo Comparator
Participants will receive a single weight-based dose of placebo via intravenous infusion, 1 to 7 days prior to surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Experiencing Major Adverse Kidney Events (MAKE) (Based on serum Cystatin C [sCysC]) at Day 90 Post Cardiopulmonary Bypass (CPB)
时间窗: Day 90 post-CPB
次要结局
- To assess the efficacy of ravulizumab in reducing risk of AKI (based on sCr) following CPB(Day 90 post CPB)
研究者
研究点 (131)
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