NCT01090037已完成2 期
TRK-100STP PhaseIIb/III 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
- 892
- 主要终点
- Renal composite endpoints [Time to first occurrence of one of the following events:]
研究概览
简要总结
In Chronic Renal Failure (CRF) patients with primary glomerular disease or nephrosclerosis as the primary disease:
- To confirm the superiority of TRK-100STP over placebo
- To determine the recommended therapeutic dose in the 2 doses of TRK-100STP
- To assess the safety of TRK-100STP
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
- 18 Years 至 75 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
TRK-100STP
Experimental
干预措施: TRK-100STP high dose (Drug)
TRK-100STP
Experimental
干预措施: TRK-100STP low dose (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Renal composite endpoints [Time to first occurrence of one of the following events:]
时间窗: 2-4 year
(i) Doubling of SCr: Doubling of SCr is defined as a two-fold or greater increase in the SCr level, as compared with the baseline value (ii) ESRD (Occurrence of any of i-iii) i) Introduction of dialysis ii) Renal transplantation iii) Increase in SCr to 6.0 mg/dL or higher
次要结局
未报告次要终点
研究者
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