NCT02232906已完成4 期
Pilot Open Label Study to Evaluate Intravenous Ferric Carboxymaltose (Ferinject ®) in Patients With CKD (Pre-dialysis) With Anemia Treated With Epo and Oral Iron in Buenos Aires, Argentina
Hospital Aleman1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ESA dose requirement during the observation period after the switch from oral iron to intravenous ferric carboxymaltose treatment
研究概览
简要总结
Investigation whether a switch from oral iron to intravenous ferric carboxymaltose can reduce dose requirements of erythropoiesis-stimulating agents (ESA) and improve Hb levels and iron status in adult patients with non-dialysis-dependent CKD who were on a stable ESA/oral iron schedule for 6 months prior to enrolment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •>18 years of age
- •Creatinine clearance ≤40 mL/min
- •Hemoglobin 110-120 g/L
- •Serum ferritin <100 µg/L or transferrin saturation <20%
- •Monthly treatment with ESA and oral iron for at least six months before enrolment
排除标准
- •Other obvious cause of acute or chronic anemia than iron deficiency
- •Expectation to require hemodialysis within the next six months
- •Short life expectancy (<1 year)
- •Pregnancy
- •Decompensated heart failure
- •History of allergic reactions to iron preparations and/or anaphylaxis from any cause
- •Requirement of blood transfusions
- •Chronic decompensated mental disorder or dementia
研究组 & 干预措施
intravenous ferric carboxymaltose
Experimental
干预措施: intravenous ferric carboxymaltose (Drug)
结局指标
主要结局
ESA dose requirement during the observation period after the switch from oral iron to intravenous ferric carboxymaltose treatment
时间窗: 6 months
次要结局
- Proteinuria at baseline and then bi-monthly until end of study as marker of renal function(6 months)
- Creatinine clearance at baseline and then bi-monthly until end of study as marker of renal function(6 months)
- Number of hospitalizations(6 months)
- Number of transfusions(6 months)
- Number of adverse reactions(6 months)
- Anaemia and iron status(6 months)
研究者
Jorge Eduardo Toblli
Full Professor of Medicine at University of Buenos Aires, Argentina, and Director of the Laboratory of Experimental Medicine, Hospital Alemán, Buenos Aires.
Hospital Aleman
研究点 (1)
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