NCT01017276已完成3 期
A Phase 3 Study in Patients With Chronic Kidney Disease (CKD) With Hyperphosphatemia on Peritoneal Dialysis
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
- Serum phosphorus level at treatment discontinuation
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 in chronic kidney disease and hyperphosphatemia patients on peritoneal dialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 peritoneal dialysis
- •Hyperphosphatemia
- •Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not 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)
结局指标
主要结局
Serum phosphorus level at treatment discontinuation
时间窗: During the 12-week treatment period
次要结局
- Percent of the patients meeting the target range of serum phosphorus levels(During treatment)
- Time-course changes in serum calcium levels(During Treatment)
- Changes in serum Ca x P(During Treatment)
- Changes in intact PTH levels(During Treatment)
研究者
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