Phase III Randomized Study of SYNSORB Pk in Children With E. Coli-Associated
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 145
- 试验地点
- 27
- 主要终点
- Time to dialysis
研究概览
简要总结
OBJECTIVES: I. Determine the effect of SYNSORB Pk therapy on mortality and frequency of severe extrarenal complications observed in children with acute stage E. coli-associated hemolytic uremic syndrome.
II. Determine the effect of SYNSORB Pk therapy on the need for the duration of dialysis in these patients.
III. Determine the effect of SYNSORB Pk therapy on the recovery of renal function and resolution of urinary abnormalities in these patients.
详细描述
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to receive either SYNSORB Pk or placebo.
Patients receive oral SYNSORB Pk or placebo three times daily for 7 days. Patients are followed on days 7, 14, 28, and 60 after discharge from the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SYNSORB Pk
Oral Shiga toxin-binding agent (500 mg/kg/day)
干预措施: SYNSORB Pk (Drug)
Placebo
Cornmeal placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to dialysis
时间窗: 60 days
Time to death or serious extrarenal events
时间窗: 60 days
次要结局
未报告次要终点