跳至主要内容
临床试验/NCT00233597
NCT00233597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 Hemodialysis Patients Who Are Receiving Supplemental EPO Therapy

AMAG Pharmaceuticals, Inc.50 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2004年8月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
230
试验地点
50
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 on hemodialysis.

详细描述

This study will evaluate the efficacy and safety of intravenous (IV) iron (ferumoxytol) as compared to oral iron in the treatment of anemia in hemodialysis patients receiving erythropoietin. Patients are randomized to receive either two doses of 510 mg of intravenous ferumoxytol in sequential dialysis sessions 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
Parallel
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

入选标准

  • Male or female patients ≥18 years.
  • Chronic hemodialysis.
  • Stable supplemental EPO therapy.
  • Baseline hemoglobin of ≤ 11.5 g/dl.

排除标准

  • Women who are pregnant or who are breast feeding.
  • 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 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

The mean change in hemoglobin from baseline.

次要结局

  • Change in iron indices.

研究者

申办方类型
Industry

研究点 (50)

Loading locations...

相似试验