EUCTR2015-003017-26-DE进行中（未招募）1 期
A Phase 2, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects with Moderate Renal Impairment and Acute Myocardial Infarction
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 81
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Men or women aged at least 18 years of age, with body weight 50 kg or more
- •Evidence of moderate RI (estimated glomerular filtration rate [eGFR] = 30 and < 60 mL/min/1.73 m2) as calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation)
- •Evidence of myocardial necrosis in a clinical setting consistent with a type I (spontaneous) AMI
- •Documented evidence of stable hepatic and renal function and no clinical suspicion of acute kidney injury (AKI) at least 12 hours after the first medical contact for the index AMI.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 41
排除标准
- •Symptoms, biomarker elevation or electrocardiogram (ECG) changes other than those of the index event that are consistent with a diagnosis of AMI but are likely not due to primary myocardial ischemia
- •Ongoing hemodynamic instability
- •Planned coronary artery bypass surgery
- •Evidence of hepatobiliary disease
- •History of acute kidney injury (AKI) after previous exposure to an intravenous contrast agent.
- •History of nephrotic range proteinuria.
- •Known history of allergy to soy beans or peanuts, immunoglobulin A (IgA) deficiency, antibodies to IgA , or hypersensitivity to CSL112 or any of its components.
- •Other severe comorbid condition, concurrent medication, or other issue that renders the subject unsuitable for participation in the study.
研究者
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