CTRI/2024/09/074184尚未招募Phase 3 4
Iron isomaltoside versus Ferric carboxymaltose in Iron Deficiency Anemia: A randomized clinical trial
Command Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月4日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Increase in Hemoglobin
研究概览
简要总结
Management of iron deficiency anemia using intravenous (IV) iron preparation is currently well established.
However, there are not safe and effective options. The commonly used IV Iron preparation in our clinical
setting is ferric carboxymaltose (FCM).
Iron isomaltoside is a new intravenous (IV) iron preparation. However, it
is not being used by us as the Indian data on safety and efficacy are scarce. In this study we aim to compare the safety and efficacy of these two IV iron preparations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Hemoglobin less than 13g/dL male, and less than 12g/dL female
- •Mean corpuscular volume less than 80 fL
- •Transferrin saturation less than 20%
- •S Ferritin less than 50 ng/mL male, 30 ng/mL for female.
排除标准
- •Patients receiving other modalities of treatment and/or alternative medicine.
- •Patients who did not consent for the study.
- •Patients with CKD, CLD, malignancy, hemoglobinopathy, and pregnant ladies.
结局指标
主要结局
Increase in Hemoglobin
时间窗: 06 weeks
次要结局
- 1. Rise in Hemoglobin(2. Reticulocyte response)
研究者
Maj Dr D Mohanasundharam
COMMAND HOSPITAL (CENTRAL COMMAND) LUCKNOW
研究点 (1)
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