Comparison of Safety & Efficacy of a Unique Intravenous Iron (VIT45) Preparation vs Oral Iron 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
- 255
- 试验地点
- 1
- 主要终点
- Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL
研究概览
简要总结
This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).
详细描述
This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females > or = 12 years of age
- •NDD-CKD subjects
- •Baseline hemoglobin < or = 11g/dl
- •Stable erythropoietin (EPO) status
排除标准
- •Known hypersensitivity to ferrous sulfate or IV iron
- •Unstable EPO status
- •Anemia not related to CKD
- •Chronic, serious infection
- •Recent IV iron
- •Recent blood transfusion
- •Recent blood loss
- •Need for surgery
- •Received investigational drug within 30 days
- •Female subjects who are pregnant or lactating
研究组 & 干预措施
Ferric Carboxymaltose (FCM)
A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
干预措施: Ferric Carboxymaltose (FCM) (Drug)
Ferrous Sulfate tablets
325 mg/TID x 8 weeks
干预措施: Ferrous Sulfate tablets (Drug)
结局指标
主要结局
Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL
时间窗: anytime during the study
次要结局
未报告次要终点