NCT00354692已完成4 期
A Randomized Cross-over Pilot Study of the Effect of Sodium Ferric Gluconate Complex vs. Iron Sucrose on Proteinuria in Non-dialysis Chronic Kidney Disease Patients
Watson Pharmaceuticals0 个研究点目标入组 12 人开始时间: 2006年6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
- 12
- 主要终点
- Change in urine protein
研究概览
简要总结
This pilot 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
- Crossover
- 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
- •Moderate to severe anemia
- •Iron deficiency
- •Moderate to severe chronic kidney disease
- •Age ≥ 18 or greater and able to give informed consent
排除标准
- •Receiving dialysis
- •Known sensitivity to Sodium Ferric Gluconate Complex in Sucrose Injection, Iron sucrose USP, or any of their components
- •Clinically unstable
- •Indication of iron sufficiency
研究组 & 干预措施
Experimental
Experimental
干预措施: Sodium Ferric Gluconate and Iron sucrose (Drug)
结局指标
主要结局
Change in urine protein
时间窗: 180 minutes
次要结局
- Change in various urine chemicals(180 minutes)
研究者
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