NCT03286205撤回4 期
A Randomized Study to Compare the Dosing Schedule of INFeD in Anemic Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- superior dosing regimen exists for INfed
研究概览
简要总结
The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is superior for the treatment of iron deficient anemia.
详细描述
The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is superior for the treatment of iron deficient anemia. The two dosing regimens under review are a low dose weekly or a larger dose given every three weeks.
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
- 是
入选标准
- •Patients over the age of 18 years old.
- •Being treated by a Sutter Health Physician.
- •Hemoglobin of < 10mg/dl for Men and Women
- •Ferritin </= 10ng/ml
- •Patients in whom oral administration is unsatisfactory or impossible.
排除标准
- •Patients with a history of receiving iron or other hematinic in the preceding 3 months, oral iron is allowable.
- •Anemia due to acute blood loss; menorrhagia is allowed.
- •Patients with a current illness known to interact with iron status.
- •Patients unwilling to consent to required blood draws.
- •Patients who are viewed as unable to complete treatment, based on PI recommendation.
研究组 & 干预措施
Weekly Dosage
Active Comparator
weekly dose of 100mg
干预措施: IV iron (Drug)
3 week dosage
Active Comparator
every 3 week dosage.
干预措施: IV iron (Drug)
结局指标
主要结局
superior dosing regimen exists for INfed
时间窗: 3 years
shown by a 2gm/dl increase in HgB
High Dose Effect
时间窗: 3 years
INfed can be given at high dose without an increase in AE and/or SAEs frequency
次要结局
未报告次要终点
研究者
David Adkins
Principal Investigator
Sutter Gould Medical Foundation
研究点 (1)
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