NCT01742611已完成3 期
ASP1585 Phase 3 Long-term Study in Chronic Kidney Disease Patients With Hyperphosphatemia Not on 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
- 105
- 主要终点
- Time-course changes in serum phosphorus levels
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 patients with hyperphosphatemia not on dialysis.
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
- •Patients who completed study 1585-CL-0101 or new patients who meet following criteria
- •Chronic kidney disease patients (eGFR < 60 mL/min/1.73 m2)
- •Serum phosphorus measurement ≧4.6 mg/dl, <9.0 mg/dl
- •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
ASP1585 group
Experimental
干预措施: ASP1585 (Drug)
结局指标
主要结局
Time-course changes in serum phosphorus levels
时间窗: During 48 week treatment
次要结局
- Achievement rate of the target range of serum phosphorus level(During 48 week treatment)
- Time to achieve the target range of serum phosphorus level(During 48 week treatment)
- Time-course changes in serum calcium levels(During 48 week treatment)
- Time-course changes in serum intact PTH (parathyroid hormone) levels(During 48 week treatment)
- Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs(During 48 week treatment)
研究者
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