NCT01897519终止2 期
A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Major Surgery
AbbVie23 个研究点 分布在 2 个国家目标入组 56 人开始时间: 2013年5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
- 终止
- 发起方
- 入组人数
- 56
- 试验地点
- 23
- 主要终点
- Change in urine Neutrophil Gelatinase-Associated Lipocalin (NGAL)
研究概览
简要总结
This study will evaluate the safety and efficacy of ABT-719 in patients undergoing high risk major 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing high risk major surgery in subjects with cardiovascular disease who are at risk of AKI.
排除标准
- •Ongoing or recent history of sepsis
- •Has recent documented acute kidney injury.
- •Subject is scheduled to have a total or partial nephrectomy.
研究组 & 干预措施
Arm 1 lower dose ABT-719
Experimental
干预措施: ABT-719 (Drug)
Arm 2 intermediate dose ABT-719
Experimental
干预措施: ABT-719 (Drug)
Arm 3 high dose ABT-719
Experimental
干预措施: ABT-719 (Drug)
Arm 4 Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in urine Neutrophil Gelatinase-Associated Lipocalin (NGAL)
时间窗: Day 0 to Day 7
Comparison between each ABT-719 dose group versus placebo in the mean maximal change from baseline in urine NGAL from Day 0 - Day 7.
次要结局
- Proportion of subjects that develop composite event at 90 days post surgery(90 Day)
- Proportion of subjects that develop a composite event at 60 days post surgery(60 Days)
- Proportion of subjects that develop the Acute Kidney Injury Network (AKIN) scoring criteria(Day 7)
- Proportion of subjects that develop the Kidney Disease Improving Global Outcomes (KDIGO) scoring criteria(Day 7)
研究者
研究点 (23)
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