NCT01256372已完成2 期
An Explorative Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
This study investigates the effect of two dose-levels of AP214 on the prevention of (acute) kidney injury after 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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Has signed the trial-specific informed consent form.
- •Patients ≥ 18 years old, male or female, not of childbearing potential (postmenopausal or permanently sterilized, e.g. tubal ligation, hysterectomy, bilateral salpingectomy), regardless of ethnicity.
- •Patients undergoing combined coronary artery bypass grafting (CABG) surgery and surgery of one or more cardiac valve (valve(s) surgery), or
- •Patients undergoing surgery of more than one cardiac valve (valves surgery), or
- •Patients undergoing surgery of the aortic root or ascending part of the aorta, or
- •Patients undergoing surgery of the aortic root or ascending part of the aorta, combined with CABG and/or valve(s) surgery, or
- •Patients with stage III chronic kidney disease (eGFR 30-59 ml/min determined by the Modification of Diet in Renal Disease (MDRD formula)) undergoing CABG or Valve surgery
排除标准
- •Cardiac surgery to be performed "off pump" without cardiopulmonary bypass.
- •Cardiac surgery to be performed with hypothermic circulatory arrest.
- •Confirmed or suspected endocarditis.
- •EF ≤ 20%, evaluated within 2 months prior to screening visit.
- •Requiring a reoperation on one of the valves within 3 months following the original valve surgical procedure.
- •Active peptic ulcer disease and gastritis.
- •Receiving dopamine, adrenalin or noradrenalin at any dose at any time 14 days prior to Day of surgery.
- •Known or suspected hypersensitivity to the investigational medicinal product.
- •Current participation in any other interventional clinical trial.
- •Previously dosed with AP
- •Use of investigational medicinal products within the previous 6 months.
- •Body weight above 130 kg.
- •History of any organ transplant.
- •Women who are of childbearing potential, pregnant, or breast-feeding.
- •Current abuse of alcohol or substance, according to the investigator's medical judgment.
- •Has a mental incapacity or language barriers precluding adequate understanding of trial procedures.
- •Any history of cancer within the last 2 years
- •Any history of dialysis.
- •Is considered by the Investigator unsuitable to participate in the trial for any other reason, for instance due to a significant serious underlying condition.
研究组 & 干预措施
AP214; dose-level 1
Experimental
AP214; dose-level 1
干预措施: AP214 (Drug)
AP214; dose-level 2
Experimental
AP214; dose-level 2
干预措施: AP214 (Drug)
Placebo to AP214
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: 90 days
To assess the safety and tolerability of AP214 compared to placebo; by analysis of number and nature of Adverse Events (AEs), Serious Adverse Events (SAEs), changes in laboratory parameters and overall health status
Efficacy
时间窗: 7 days
To assess the effect of AP214 versus placebo on the maximal postoperative change in absolute values of Serum Creatinine (SCr) compared to baseline within the first 7 days after surgery or until discharge from hospital, whichever comes first
次要结局
- Efficacy(90 days)
研究者
研究点 (1)
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