NCT00892749已完成3 期
A Phase 3, Long-term Study in Patients With Chronic Kidney Disease (CKD) and Hyperphosphatemia on Hemodialysis
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
- 248
- 主要终点
- Changes in serum Phosphorus level
研究概览
简要总结
This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 for long-term dosing in chronic kidney disease and hyperphosphatemia patients on hemodialysis.
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
- •Chronic kidney disease patients on hemodialysis
- •Hyperphosphatemia
- •Written informed consent
排除标准
- •Patients with gastrointestinal surgery or enterectomy
- •Severe cardiac disease patients
- •Patients with severe constipation or diarrhea
- •Patients with a complication of malignant tumors
- •Patients with uncontrolled hypertension
- •Patients treated with parathyroid intervention
研究组 & 干预措施
1. ASP1585
Experimental
干预措施: ASP1585 (Drug)
结局指标
主要结局
Changes in serum Phosphorus level
时间窗: After 48 weeks
次要结局
- Changes in intact PTH level(After 48 weeks)
- Percent of the patients meeting the target range of serum Phosphorus levels(During the treatment)
- Changes in serum Calcium level(After 48 weeks)
- Changes in serum Ca x P(After 48 weeks)
研究者
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