NCT00224003已完成4 期
Open-Label, Multi-Center Study of the Safety and Efficacy of Ferrlecit® in the Maintenance of Iron Stores in Pediatric Hemodialysis Patients Receiving Epoetin
Watson Pharmaceuticals10 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2003年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 10
- 主要终点
- Transferrin Saturation
研究概览
简要总结
A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal guardian had provided signed informed consent, and who had satisfied the inclusion and exclusion criteria of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female pediatric ESRD, Patients >_ 2 and <_ 16 years of age, whose legally authorized representative provided signed informed consent.
- •Stabilized on chronic hemodialysis therapy with an identified need for maintenance iron therapy.
- •Predetermined TSAT and serum Ferritin (at the screening visit).
- •Receiving a stable EPO dosing regimen.
排除标准
- •Receipt of any form of iron supplementation during the 2 weeks prior to the first Ferrlecit dosing.
- •Hypersensitivity to Ferrlecit or any of its inactive components.
- •High TSAT level.
- •High Serum Ferritin
结局指标
主要结局
Transferrin Saturation
时间窗: 14 weeks
Change from baseline to 2 weeks after last dose
Serum Ferritin
时间窗: 14 weeks
Change from baseline to 2 weeks after last Fe dose
次要结局
- Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety.(14 weeks)
研究者
研究点 (10)
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