NCT01850602已完成3 期
A Phase III 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
- 213
- 主要终点
- Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of PA21 in hemodialysis patients with hyperphosphatemia
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 20 or older, regardless of gender.
- •Receiving stable maintenance hemodialysis 3 times a week.
- •Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start.
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)
Sevelamer hydrochloride
Active Comparator
干预措施: Sevelamer hydrochloride (Drug)
结局指标
主要结局
Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment
时间窗: 12 weeks
Covariate: Serum phosphorus concentrations at baseline.
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)
研究者
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