NCT01852682已完成3 期
A Phase III Study of PA21 in Peritoneal Dialysis Patients With Hyperphosphatemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 主要终点
- Serum phosphate concentrations
研究概览
简要总结
The purpose of this study is to investigate efficacy and safety, when administering PA21, in peritoneal dialysis patients having hyperphosphatemia.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving stable maintenance peritoneal dialysis
- •Peritoneal dialysis patients with hyperphosphatemia
排除标准
- •Patients having history of a pronounced brain / cardiovascular disorder
- •Patients having severe gastrointestinal disorders
- •Patients having severe hepatic disorders
研究组 & 干预措施
PA21
Experimental
干预措施: PA21 (Drug)
结局指标
主要结局
Serum phosphate concentrations
时间窗: 12 weeks
次要结局
- Incidences of Adverse Events(28 weeks)
- Serum phosphate concentrations(28 weeks)
研究者
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