NCT00704483已完成2 期
A 12-week, Open Label, Multicenter, Titration Study, With a 9-month Maintenance Treatment Extension, to Demonstrate Efficacy of SBR759 Compared to Sevelamer HCl in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 3
- 主要终点
- Responder rates in target serum phosphate levels at 12 weeks Evaluate efficacy of SBR759 compared to sevelamer HCl at 12 weeks
研究概览
简要总结
This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis
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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
1g tid
干预措施: SBR759 (Drug)
2
Active Comparator
Sevelamer HCl
干预措施: Sevelamer HCl (Drug)
3
Experimental
SBR759 1.5 g tid
干预措施: SBR759 (Drug)
4
Active Comparator
Sevelamer HCl
干预措施: Sevelamer HCl (Drug)
结局指标
主要结局
Responder rates in target serum phosphate levels at 12 weeks Evaluate efficacy of SBR759 compared to sevelamer HCl at 12 weeks
时间窗: Time Frame: 12 weeks + 12 months
次要结局
- Responder rates in target patients with serum calcium-phosphate levels at 12 weeks/12 months(Time Frame: 12 weeks / 12 months)
研究者
研究点 (3)
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