Open Label Extension Study Evaluating the Long Term Safety, Tolerability and Efficacy of an Iron Maintenance Dosing Strategy Utilizing Intravenous VIT45 in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-emergent Adverse Events
研究概览
简要总结
The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004 (NCT00317239).
详细描述
The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004.
In this study patients that complete protocol 1VIT 04004 or are discontinued will be offered to participate in this extension study.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who completed or discontinued Protocol 1VIT04004
排除标准
- •Known hypersensitivity reaction to VIT-45
- •Anemia not related to CKD
- •Chronic, serious infection
- •Recent IV iron other than study drug in past 12 weeks
- •Recent blood loss within the last 12 weeks
- •Need for surgery or dialysis
- •Female subjects who are pregnant or lactating
研究组 & 干预措施
Ferric Carboxymaltose (FCM)
maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit
干预措施: Ferric Carboxymaltose (FCM) (Drug)
结局指标
主要结局
Incidence of Treatment-emergent Adverse Events
时间窗: 44 week study duration
次要结局
未报告次要终点