NCT01742585已完成3 期
ASP1585 Phase 3 Randomized Double Blind Placebo-controlled Study in Chronic Kidney Disease (CKD) 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
- 163
- 主要终点
- Change from baseline in serum phosphorus level at the end of treatment
研究概览
简要总结
This is a randomized, double blind, placebo-controlled multi-center study to examine the efficacy and safety of ASP1585 in chronic kidney disease patients with hyperphosphatemia not on dialysis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 (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 within 6 months
研究组 & 干预措施
ASP1585 group
Experimental
干预措施: ASP1585 (Drug)
placebo group
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change from baseline in serum phosphorus level at the end of treatment
时间窗: Baseline and Week 12 or treatment discontinuation
次要结局
- Time to achieve the target range of serum phosphorus level(During 12 week treatment)
- Achievement rate of the target range of serum phosphorus level(During 12 week treatment)
- Time-course changes in serum phosphorus levels(During 12 week treatment)
- Time-course changes in serum calcium levels(During 12 week treatment)
- Safety assessed by the incidence of adverse events, vital signs, labo-tests and 12-lead ECGs(During 12 week treatment)
研究者
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