NCT01850641已完成3 期
A Phase III Study of PA21 With Calcium Carbonate 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
- 35
- 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 when administering PA21 with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.
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: 12 weeks
次要结局
- Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)(12 weeks)
- Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)(12 weeks)
- Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)(12 weeks)
- Serum Ferritin Concentrations at End of Treatment (Actual Measured Value)(12 weeks)
- Constipation Condition(12 weeks)
- Hb Concentrations at End of Treatment (Actual Measured Value)(12 weeks)
- Satisfaction With Bowel Movement(12 weeks)
- TSAT at End of Treatment (Actual Measured Value)(12 weeks)
研究者
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