NCT02676401已完成2 期
An Extended Treatment Study of MT-3995 in Patients With Diabetic Nephropathy
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
- 241
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This study aims to evaluate the safety and efficacy of MT-3995 administered over the longer term, following MT-3995-J05 study.
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
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent for participation before the completion of MT-3995-J05 Study
- •Completion of MT-3995-J05 study
排除标准
- •UACR of ≥300 mg/g Cr with an increase of ≥30% in MT-3995-J05 Study
- •Symptomatic and clinically significant hypotension
- •QT prolongation or torsades de pointes
- •New York Heart Association (NYHA) Class III or IV heart failure
- •Patients who are judged to be unsuitable for participation based on their safety profile in MT-3995-J05 Study
研究组 & 干预措施
MT-3995 Low
Experimental
干预措施: MT-3995 Low (Drug)
MT-3995 Middle
Experimental
干预措施: MT-3995 Middle (Drug)
MT-3995 High
Experimental
干预措施: MT-3995 High (Drug)
结局指标
主要结局
Adverse events
时间窗: From baseline to 28 weeks
次要结局
- Change from baseline in Urine Albumin to Creatinine Ratio (UACR)(baseline and Week 28)
研究者
研究点 (1)
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