NCT00704028已完成3 期
A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of Intravenous Ferric Carboxymaltose (FCM) vs. Iron Dextran in Treating Iron Deficiency Anemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's)
研究概览
简要总结
The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.
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
- •Subjects ≥18 years of age and able to give informed consent
- •Iron deficiency is the primary etiology of anemia
- •History of intolerance or an unsatisfactory response to oral iron
- •Screening Visit central laboratory Hgb ≤11 g/dL
- •Screening Visit ferritin ≤100 ng/mL or ≤300 when TSAT was ≤30%
排除标准
- •Previous participation in a FCM trial
- •Known hypersensitivity reaction to FCM or iron dextran
- •Requires dialysis for treatment of chronic kidney disease
- •Current anemia not attributed to iron deficiency
- •Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase
- •Anticipated need for surgery during the 30 day period prior to screening or during the study period
- •AST or ALT greater than 1.5 times the upper limit of normal
- •Received an investigational drug within 30 days of screening
- •Women who are breastfeeding
- •Pregnant or sexually-active females who are not willing to use an effective form of birth control
研究组 & 干预措施
Ferric Carboxymaltose (FCM)
Experimental
15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.
干预措施: Ferric Carboxymaltose (Drug)
Iron Dextran
Active Comparator
As determined by the investigator to a maximum cumulative dose of 2,250 mg.
干预措施: Iron Dextran (Drug)
结局指标
主要结局
The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's)
时间窗: Day 0 through end of study (Day 42), or 28 days after the last dose of study drug whichever was longer
次要结局
未报告次要终点
研究者
研究点 (1)
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