NCT02480751已完成2 期
TRK-100STP PhaseII Clinical Study -Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 113
- 主要终点
- Difference between the run-in and treatment periods in the slope of the regression line of 1/SCr versus time
研究概览
简要总结
The purpose of this study is to determine the recommended dose of the sustained-release form of BPS (TRK-100STP low dose or high dose) in Japanese patients with CRF (Primary glomerular disease/nephrosclerosis).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The CRF patient with primary glomerular disease or nephrosclerosis as the primary disease
- •The patient with progressive CRF
排除标准
- •The patient with secondary glomerular disease
- •The patient with CRF caused by pyelonephritis, interstitial/tubular nephritis, gouty kidney, polycystic kidney disease, or nephroureterolithiasis
研究组 & 干预措施
1: Exprimental (TRK-100STP)
Experimental
high dose
干预措施: Beraprost (Drug)
2: Exprimental (TRK-100STP)
Experimental
low dose
干预措施: Beraprost (Drug)
3: Placebo Comparator
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Difference between the run-in and treatment periods in the slope of the regression line of 1/SCr versus time
时间窗: 50 weeks (Run-in 22weeks, Treatment 28 weeks)
次要结局
未报告次要终点
研究者
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