EUCTR2012-005710-19-DK进行中（未招募）不适用
A Phase 2b, Randomized, Double-Blind,Placebo-Controlled, Safety and Efficacy Trial ofMultiple Dosing Regimens of ABT-719 for thePrevention of Acute Kidney Injury in SubjectsUndergoing High Risk Major Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
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
- •1. Subject must be male or female, age >= 18 years old
- •2. Subject undergoing open aortic surgery or open surgery of the renal artery
- •Subject undergoing surgery (vascular surgery, endovascular surgery, non-CPB cardiac surgery or transcatheter aortic valve replacement (TAVR)) of anticipated duration of > =2 hours with a least one of the follwing:
- •a. eGFR > 15 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 as determined by CKD EPI formula at Screening, OR
- •b. Subject is Type 1 or 2 diabetic requiring anti-diabetic medication (oral or insulin), OR
- •c. Subject has documented history of proteinuria > 0.3 g/day (spot urine protein/creatinine ratio [UPCR] >= 0.3 g/g or urine dip stick 2+ or more evaluated at screening
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 340
排除标准
- •1. Active peptic ulcer disease with history of upper GI bleed.
- •2. Has ongoing sepsis or history of sepsis within the last 2 weeks or
- •untreated diagnosed infection prior to Screening visit
- •3. Has known/documented history of RIFLE or AKIN within the previous 4 weeks
- •4. Subject with cancer and on active nephrotoxic chemotherapy (treatment), or have received (nephrotoxic chemotherapy in the previous 10 weeks), or are expecting to receive nephrotoxic chemotherapy in the next 3 months and/or life expectancy of 1 year or less
研究者
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