临床试验/NCT00534144

NCT00534144已完成1 期

A Randomized Controlled Trial of the Effect of IV Iron on Proteinuria in Non-Dialysis Chronic Kidney Disease Patients

Watson Pharmaceuticals0 个研究点目标入组 74 人开始时间: 2007年9月最近更新: 2011年9月23日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 74
主要终点: Change in urine protein

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study will compare the effects of sodium ferric gluconate complex and iron sucrose on urine concentrations of various chemicals including protein

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Basic Science
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

•Moderate to severe anemia
•Iron deficiency
•Moderate to severe chronic kidney disease, not receiving dialysis
•Age ≥ 18 or greater and able to give informed consent

排除标准

•Known sensitivity to Sodium Ferric Gluconate Complex in Sucrose Injection, Iron sucrose USP, or any of their components
•Clinically unstable
•Indication of iron sufficiency
•Bladder obstruction conditions that would not allow for good urine output

研究组 & 干预措施

Iron Sucrose

Active Comparator

干预措施: iron sucrose injection, USP (Drug)

Ferric Gluconate

Active Comparator

干预措施: sodium ferric gluconate complex in sucrose injection (Drug)

结局指标

主要结局

Change in urine protein

时间窗: 6 weeks

次要结局

未报告次要终点

研究者

发起方

Watson Pharmaceuticals

申办方类型

Industry

责任方

Sponsor

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