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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 83
- 试验地点
- 31
- 主要终点
- Percent of Participants With at Least One Occurrence of Treatment-emergent Renal Serious Adverse Events (SAEs) (SAF)
研究概览
简要总结
This study is a phase 2, multicenter, double-blind, randomized, placebo controlled, parallel-group study to investigate the renal safety and tolerability of multiple dose intravenous (IV) administration of CSL112 compared with placebo in subjects with moderate renal impairment (RI) and acute myocardial infarction (AMI).
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
- Double (Participant, Investigator)
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
- •Men or women, at least 18 years of age, with evidence of moderate renal impairment (an eGFR ≥ 30 and <60 mL/min/1.73 m2) and myocardial necrosis in a clinical setting consistent with a type I (spontaneous) acute myocardial infarction (AMI).
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.
研究组 & 干预措施
Placebo
Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.
干预措施: Placebo (Other)
CSL_112
CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).
干预措施: CSL_112 (Biological)
结局指标
主要结局
Percent of Participants With at Least One Occurrence of Treatment-emergent Renal Serious Adverse Events (SAEs) (SAF)
时间窗: Up to 9 weeks
A renal SAE is defined as any SAE with a MedDRA preferred term included in the Acute Renal Failure narrow Standard MedDRA Query or a preferred term of renal tubular necrosis, renal cortical necrosis, renal necrosis, or renal papillary necrosis.
Percent of Participants With Treatment-emergent Acute Kidney Injury (AKI )
时间窗: Up to 4 weeks
Acute kidney injury is defined as an absolute increase in serum creatinine from baseline ≥ 0.3 mg/dL during the Active Treatment Period that is sustained upon repeat measurement by the central laboratory no earlier than 24 hours after the elevated value. If no repeat value is obtained, a single serum creatinine value that is increased from baseline ≥ 0.3 mg/dL (26.5 μmol/L) during the Active Treatment Period would also fulfil the definition of AKI.
次要结局
- Baseline-corrected Plasma Concentration Maximum (Cmax) After Infusion 1 for apoA-I and PC(Immediately after end of infusion)
- Total Number of TEAEs(Up to 9 weeks)
- Percentage of Participants With Change in Renal Status(Baseline and up to 4 weeks)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Up to 9 weeks)
- Percentage of Participants With TEAEs(Up to 9 weeks)
- Number of Participants With Treatment-emergent Adverse Drug Reaction (ADR) or Suspected ADR(Up to 9 weeks)
- Percentage of Participants With Treatment-emergent Adverse Drug Reaction (ADR) or Suspected ADR(Up to 9 weeks)
- Number of Participants With Change in Renal Status(Baseline and up to 4 weeks)
- Number of Participants With Change in Hepatic Status(Baseline and up to 4 weeks)
- Percentage of Participants With Treatment-emergent Bleeding Events(Up to 9 weeks)
- Plasma apoA-I and Phosphatidylcholine (PC) Accumulation Ratio After Infusion 4(Immediately after end of infusion)
- Percentage of Participants With Change in Hepatic Status(Baseline and up to 4 weeks)
- Number of Participants With Treatment-emergent Bleeding Events(Up to 9 weeks)
- Percentage of Participants With Binding Antibodies Specific to Apolipoprotein A-I (Apo-A1) and CSL112(Up to 9 weeks)
- Baseline-corrected Plasma Concentration Maximum (Cmax) After Infusion 4 for apoA-I and PC(Immediately after end of infusion)