NCT01057407已完成3 期
A Phase 3, Multicenter, Open-label, Sevelamer Hydrochloride-controlled Study in Chronic Kidney Disease (CKD) Patients With 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
- 110
- 主要终点
- Serum phosphorus level at the end of treatment
研究概览
简要总结
This is a multi-center, open-labeled study to examine the non-inferiority of ASP1585 to sevelamer hydrochloride in chronic kidney disease patients with hyperphosphatemia on hemodialysis.
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
- •Chronic kidney disease patients on hemodialysis
- •Hyperphosphatemia
- •Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not been changed within 28 days
- •Written informed consent
排除标准
- •Patients with gastrointestinal surgery or enterectomy
- •Patients with severe cardiac diseases
- •Patients with severe constipation or diarrhea
- •Patients with a history or complication of malignant tumors
- •Patients with uncontrolled hypertension
- •Patients treated with parathyroid intervention
研究组 & 干预措施
ASP group
Experimental
干预措施: ASP1585 (Drug)
Sevelamer group
Active Comparator
干预措施: Sevelamer hydrochloride (Drug)
结局指标
主要结局
Serum phosphorus level at the end of treatment
时间窗: After 12-week or at the treatment discontinuation
次要结局
- Changes in intact PTH levels(During Treatment)
- Change in serum phosphorus level(After 12-week or at the end of treatment)
- Changes in serum Ca x P(During treatment)
- Time-course changes in serum phosphorus levels(During Treatment)
研究者
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