NCT01151592撤回4 期
Assessment of Safety of Iron Sucrose (Venofer) in Patients With Chronic Kidney Disease Who Cannot Tolerate Ferumoxytol (Feraheme) or Iron Dextran (INFed or Dexferrum)
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Incidence and severity of adverse events, overall and related from Day of first iron sucrose administration through the end of the study.
研究概览
简要总结
The objective of this study is to assess the safety and tolerability of Venofer in patients with chronic kidney disease who cannot tolerate Ferumoxytol (Feraheme) or intravenous iron containing a dextran (INFed or Dexferrum).
详细描述
This is a Phase IV, multi-center, open label study that assesses the safety and tolerability of Iron Sucrose (Venofer) in subjects with CKD who require intravenous iron for the treatment of iron deficiency anemia (IDA) but cannot tolerate Ferumoxytol or Iron Dextran.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 subjects > or = to 18 years of age
- •Determined by treating physician to have chronic kidney disease and require a course of intravenous iron
- •Subject did not tolerate an intravenous iron containing a dextran or Ferumoxytol within the last year
- •Subjects with hemodialysis-dependent or peritoneal dialysis chronic kidney disease should be receiving an erythropoiesis stimulating agent (ESA) as per the iron sucrose package insert
排除标准
- •Known history of hypersensitivity or significant intolerance to iron sucrose
- •Evidence of iron overload
- •Hemochromatosis or other iron storage disorders
- •Received an investigational drug within 30 days of screening
- •Any other laboratory abnormality, medical condition or psychiatric disorder which would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements
- •Pregnant or sexually-active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception
结局指标
主要结局
Incidence and severity of adverse events, overall and related from Day of first iron sucrose administration through the end of the study.
时间窗: Day 0 through 30 days after the final administration of iron sucrose
次要结局
未报告次要终点
研究者
研究点 (2)
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