NCT00255450已完成3 期
A Double Blind, Placebo Controlled, Crossover Design, Multicenter Study of Intravenous Ferumoxytol Compared With Placebo
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 750
- 试验地点
- 41
- 主要终点
- Safety evaluated by physical examinations, vital signs, laboratory tests and patient monitoring and evaluation.
研究概览
简要总结
This crossover safety study will evaluate the safety of a single dose of ferumoxytol compared to placebo in patients with chronic kidney disease.
详细描述
This is a double-blind, placebo controlled, crossover design study of the safety of ferumoxytol compared to placebo. Patients are randomized to receive either one 510 mg dose of ferumoxytol or the equivalent volume of normal saline followed by the other test article given one week later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
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
- •Male or female patients > 18 years.
- •Have chronic kidney disease per K/DOQI guidelines.
- •Baseline hemoglobin of > 9.0 and < 12.5 g/dl
排除标准
- •Women who are pregnant or lactating.
- •Received another investigational drug or device within 30 days.
- •Recent parenteral or oral iron therapy.
- •Patients that have other causes of anemia.
- •Major surgery within 30 days or anticipated or planned surgery during the study.
- •Patients with active infections.
- •Recent blood transfusions.
- •Patients with known allergies to iron products.
结局指标
主要结局
Safety evaluated by physical examinations, vital signs, laboratory tests and patient monitoring and evaluation.
次要结局
未报告次要终点
研究者
研究点 (41)
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