NCT00224042已完成4 期
A Randomized, Controlled, Open-label Study of the Safety and Efficacy of Ferrlecit® vs Oral Iron in Iron Deficient Patients With Chronic Kidney Disease Being Treated With Erythropoietic Therapy
Watson Pharmaceuticals0 个研究点目标入组 52 人开始时间: 2003年4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
- 52
- 主要终点
- Baseline Hemoglobin Concentration
研究概览
简要总结
This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents, such as Procrit® and Aranesp®.
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
- •Moderate to severe anemia
- •Iron deficiency
- •Moderate to severe chronic kidney disease
- •Receiving therapy with erythropoietic agent
排除标准
- •Receiving dialysis
- •Known sensitivity to Ferrlecit® or any of its components
- •Clinically unstable
研究组 & 干预措施
IV iron
Experimental
干预措施: Sodium Ferric Gluconate complex in sucrose (Drug)
oral iron
Active Comparator
干预措施: Ferrous sulfate tablets (Drug)
结局指标
主要结局
Baseline Hemoglobin Concentration
时间窗: Baseline
Change in Hemoglobin (Hgb)
时间窗: Baseline to 10 weeks
Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.
次要结局
- Baseline Serum Ferritin Concentration(Baseline)
- Change in Serum Ferritin(Baseline to 10 weeks)
研究者
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