NCT00224081已完成4 期
Dialysis Patients' Response to IV Iron With Elevated Ferritin
Watson Pharmaceuticals0 个研究点目标入组 134 人开始时间: 2004年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 主要终点
- Change in hemoglobin and anemia medications
研究概览
简要总结
This study explores the safety and efficacy of intravenous iron therapy in anemic hemodialysis patients treated with epoetin alfa, who have higher serum ferritin levels, but low to normal transferrin saturation.
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
- 否
入选标准
- •Chronic hemodialysis
- •Elevated serum ferritin with low to normal transferrin saturation (TSAT)
- •Moderate to severe anemia
- •Receiving epoetin alfa treatment
排除标准
- •Known sensitivity to Ferrlecit®
- •Medical conditions that would confound the efficacy evaluation
- •Recent blood transfusion
研究组 & 干预措施
Ferric gluconate
Experimental
干预措施: Sodium ferric gluconate, (Drug)
结局指标
主要结局
Change in hemoglobin and anemia medications
时间窗: 6 weeks
次要结局
- Change in various iron indices(6 weeks)
研究者
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