NCT02610283已完成2 期
A Randomized, Double-Blind, Placebo Controlled , Phase 2 Study to Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Acute Kidney Injury in Subjects at High Risk for AKI Following Cardiac Surgery
Quark Pharmaceuticals36 个研究点 分布在 3 个国家目标入组 341 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 341
- 试验地点
- 36
- 主要终点
- Proportion of subjects developing AKI as defined by the AKIN criteria
研究概览
简要总结
This trial is designed to evaluate QPI-1002 versus placebo for the prevention of AKI in subjects who are at high risk for AKI following cardiac surgery. Half of the participants will receive QPI-1002 while the other half will receive placebo.
详细描述
This is a randomized, double-blind, placebo-controlled, Phase 2 trial to evaluate QPI-1002 versus placebo for the prevention of AKI in subjects who are at high risk for AKI following cardiac surgery.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have the ability to understand the requirements of the study, are able to provide written informed consent and are willing and able to comply with the requirements of the study
- •Male or female, age ≥ 45 years old.
- •Have stable renal function per Investigator assessment and no known increase in serum creatinine of ≥ 0.3 mg/dL during preceding 4 weeks.
- •Scheduled to undergo non-emergent open chest cavity cardiovascular surgeries, including use of coronary pulmonary bypass (CPB) and no CPB:
- •Combined coronary artery bypass grafting (CABG) surgery and surgery of one or more cardiac valve (valve(s) surgery) and at least 1 AKI Risk Factor;
- •Surgery of more than one cardiac valve (valve surgery) and at least 1 AKI Risk Factor;
- •Surgery of the aortic root or ascending part of the aorta, or in combination with the aortic valve, and at least 1 AKI Risk Factor; circulatory arrest is not excluded;
- •Aortic root or ascending part of the aorta, combined with CABG and/or valve(s) surgery and at least 1 AKI Risk Factor; circulatory arrest is not excluded;
- •If only CABG or single valve surgery, subjects are required to have at least 2 AKI Risk Factors:
- •AKI Risk Factors:
- •Age ≥ 70 years
- •eGFR ≤ 60 ml/min/1.73m2 by CKD-EPI formula at Screening.
- •Diabetes (Type 1 or 2), requiring at least 1 oral hypoglycemic agent or insulin
- •Proteinuria ≥ 0.3g/d, spot UPCR ≥ 0.3g/gm or urine dip stick ≥ +2
- •History of congestive heart failure requiring hospitalization
排除标准
- •Have an eGFR ≤ 20 mL/min/1.73 m2
- •Subjects with an eGFR ≤ 60 mL/min/1.73 m2 requiring intravascular iodinated contrast within 48 hours of the day of surgery. However, subjects may be included if the post contrast increase in serum creatinine is < 0.3 mg/dl in at least 2 serum creatinine evaluations performed not less than 36 hours apart.
- •Have a history of any organ or cellular transplant which requires active immunosuppressive treatment which can interfere with kidney function
- •Emergent surgeries, including aortic dissection, and major congenital heart defects
- •Scheduled to undergo transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR) or single vessel, mid-CAB off-pump surgeries or left ventricular assist device (LVAD) implantation
- •Have participated in an investigational drug study in the last 30 days
- •Have a known allergy to or had participated in a prior study with siRNA
- •Have a history of human immunodeficiency virus (HIV) infection
- •Have known active Hepatitis B (HBV) (Note: Subjects with a serological profile suggestive of clearance, or prior antiviral treatment of HBV infection may be enrolled)
- •Are HCV-positive (detectable HCV RNA) (Note: Subjects at least 24 weeks from completion of treatment with an antiviral regimen and who remain free of HCV as determined by HCV RNA testing may be enrolled.)
- •Have had cardiogenic shock or hemodynamic instability within the 24 hours prior to surgery, requiring inotropes or vasopressors or other mechanical devices such as intra-aortic balloon counter-pulsation (IABP)
- •Have required any of the following within a week prior to cardiac surgery: defibrillator or permanent pacemaker, mechanical ventilation, IABP, left ventricular assist device (LVAD), other forms of mechanical circulatory support (MCS) (Note: The prophylactic insertion of an IABP preoperatively for reasons not related to existing LV pump function is not exclusionary).
- •Have required cardiopulmonary resuscitation within 14 days prior to cardiac surgery
- •Have ongoing sepsis or history of sepsis within the past 2 weeks or untreated diagnosed infection prior to Screening visit. Sepsis is defined as presence of a confirmed pathogen, along with fever or hypothermia, and hypoperfusion or hypotension
- •Have total bilirubin or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN) at time of screening
- •Have Child Pugh Class A liver disease with ALT/AST above the upper limit of normal or Class B or higher. (This criterion is only applicable in a patient population with underlying chronic liver disease, i.e., cirrhosis.)
研究组 & 干预措施
QPI-1002
Active Comparator
QPI-1002 Injection, single dose
干预措施: QPI-1002 (Drug)
Placebo
Placebo Comparator
isotonic saline
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects developing AKI as defined by the AKIN criteria
时间窗: Baseline through Day 5
次要结局
- Proportion of subjects developing at least on of the following events: death, needing renal replacement therapy (RRT) during the 90-day post-operative period, or having a ≥ 25% reduction in SCr based eGFR at the Day 90 visit(Baseline through Day 90)
研究者
研究点 (36)
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