Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Patients With an Increase in Hemoglobin >= 1gm/dL.
研究概览
简要总结
To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.
详细描述
The intent of this study was to assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure patients receiving or not receiving erythropoietin. After an extensive enrollment period, patients were randomized to receive oral iron (ferrous sulfate, 325mg three times daily (TID) for 56 days) or IV iron sucrose (total 1000mg, 500mg X 2 OR 200mg X 5 within two weeks). Erythropoietin schedule was to remain unchanged during the 56 day study.
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
- •Hemoglobin < or = 11.5 gm/dL
- •Stable dose or not receiving EPO
- •Renal Anemia
排除标准
- •IV iron with last 6 months
- •Chronic infection, malignancy,major surgery within last month
- •Blood Transfusion with last two months
- •Significant blood loss within last 3 months
- •Concomitant sever diseases of the liver
研究组 & 干预措施
Venofer
iron sucrose injection
干预措施: Venofer (Drug)
Ferrous Sulfate
oral iron
干预措施: Ferrous Sulfate (Drug)
结局指标
主要结局
Patients With an Increase in Hemoglobin >= 1gm/dL.
时间窗: Change from Baseline up to Day 56
次要结局
- Number of Subjects With a Clinical Response(Change from Baseline up to Day 56)
- Mean Change in Ferritin (ng/mL) From Baseline to Day 56(Change from Baseline at Day 56)
- Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56(Change from Baseline up to Day 56)
- Highest Change From Baseline in Ferritin (ng/mL) up to Day 56(Change from Baseline up to Day 56)
- Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56(Change from Baseline at Day 56)
- Mean Change From Baseline in Hemoglobin (g/dL) at Day 56(Change from Baseline at Day 56)