NCT01833494已完成3 期
A Long-term Study of PA21 in Hemodialysis 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
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy for 52-week dosing in hemodialysis patients with 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 hemodialysis 3 times a week.
- •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
Incidence of Adverse Events
时间窗: 52 weeks
次要结局
- Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)(52 weeks)
- Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)(52 weeks)
- Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)(52 weeks)
研究者
研究点 (1)
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