NCT00255437已完成3 期
A Phase III Study of the Safety and Efficacy of Ferumoxytol (Compared With Oral Iron) as an Iron Replacement Therapy in Chronic Kidney Disease Patients Not on Dialysis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 13
- 主要终点
- The mean change in hemoglobin from baseline.
研究概览
简要总结
The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients with chronic kidney disease who are not on dialysis.
详细描述
This study will evaluate the efficacy and safety of intravenous (IV) ferumoxytol as compared to oral iron in the treatment of anemia in non-dialysis dependent CKD patients. Patients are randomized to receive either two doses of 510 mg of ferumoxytol within one week or 200 mg oral elemental iron daily for three weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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.
- •No change in EPO status during study.
- •Baseline hemoglobin of ≤ 11.0 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 with active GI bleeding or acute bleeding within 4 weeks.
- •Patients that have other causes of anemia.
- •Major surgery within 30 days or anticipated or planned major surgery during the study.
- •Patients whose EPO status changes while on study.
- •Patients with active infections.
- •Recent blood transfusions.
- •Patients with any known allergies to iron products.
结局指标
主要结局
The mean change in hemoglobin from baseline.
次要结局
- Change in iron indices.
研究者
研究点 (13)
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