NCT01889277已完成1 期
A Phase II, Randomised, Double-blind, Placebo-controlled Study of MT-3995 in Subjects With Diabetic Nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Frequency and nature of treatment-emergent adverse events and serious adverse events.
研究概览
简要总结
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of MT-3995 in Subjects with Diabetic Nephropathy
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with Type 2 diabetes mellitus and diabetic nephropathy, who have been treated with a stable dose of angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB)
- •Glycosylated haemoglobin (HbA1c) ≤10.5%
- •Subject with albuminuria
排除标准
- •History of Type 1 diabetes, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
- •Serum potassium level <3.5 or >5.0 mmol/L
- •Subjects who had acute kidney injury within 3 months prior to baseline or have undergone hemodialysis at any time prior to randomisation
- •Subjects with clinically significant hypotension
研究组 & 干预措施
MT-3995-Low
Experimental
MT-3995-Low Dose
干预措施: MT-3995-Low (Drug)
MT-3995-High
Experimental
MT-3995-High Dose
干预措施: MT-3995-High (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency and nature of treatment-emergent adverse events and serious adverse events.
时间窗: 20 weeks
Plasma concentrations of MT-3995 and its major metabolite
时间窗: 20 weeks
次要结局
- Change from baseline in Urine albumin-to-creatinine ratio (UACR) and blood pressure(20 weeks)
研究者
研究点 (1)
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