A Randomized, Double-blinded, Comparative Trial Comparing the Incidence of Hypophosphatemia in Relation to Repeated Treatment Courses of Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia Due to Inflammatory Bowel Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Incidence of hypophosphatemia
研究概览
简要总结
Treatment with iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency anaemia due to inflammatory bowel disease and comparison of the incidence of hypophosphatemia
详细描述
Existing IV iron complexes differ in relation to the compounds capability to induce unintended hypophosphatemia to a degree defined as medical significant.
This trial is designed evaluate the effect of IV iron isomaltoside compared to IV ferric carboxymaltose on phosphate in subjects with IDA due to inflammatory bowel disease .
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blinded
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Iron Isomaltoside
Iron Isomaltoside (Monofer) administered IV
干预措施: Iron Isomaltoside (Drug)
Ferric Carboxymaltose
Ferric Carboxymaltose (Injectafer) administered IV
干预措施: Ferric Carboxymaltose (Drug)
结局指标
主要结局
Incidence of hypophosphatemia
时间窗: any time from baseline to day 35
s-phosphate \< 2 mg/dL
次要结局
- Incidence of hypophosphatemia(any time from baseline to week 10)
- Time with hypophosphatemia(number of days any time from baseline to week 10)
- Incidence of s-phosphate < 1.0 mg/dL(any time from baseline to day 35)