NCT01756716已完成2 期
A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect on Urine Albumin-to-Creatinine Ratio (UACR), Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of MT-3995 as Add-on Therapy to ACE-I or ARB in Type II Diabetic Nephropathy Subjects With Albuminuria and an eGFR ≥30-<60 mL/Min/1.73m^2
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
- 49
- 试验地点
- 1
- 主要终点
- Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group.
研究概览
简要总结
The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria and Moderately Decreased GFR
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
- •Subjects with Type II diabetic nephropathy, who have been treated with angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB)
- •Glycosylated haemoglobin (HbA1c) ≤10.5%
- •An estimated glomerular filtration rate (eGFR) ≥30-<60 mL/min/1.73m^2
- •Subject with albuminuria
排除标准
- •History of Type I 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 (AKI) within 3 months prior to baseline or have undergone renal dialysis at any time prior to randomisation
- •Subjects with a history of renal transplant
- •Subjects with clinically significant hypotension
研究组 & 干预措施
MT-3995 Low group
Experimental
干预措施: MT-3995 Low (Drug)
MT-3995 High group
Experimental
干预措施: MT-3995 High (Drug)
Placebo group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group.
时间窗: up to 8 weeks
Frequency and nature of treatment-emergent adverse events and serious adverse events.
时间窗: up to 16 weeks
次要结局
- Percentage change from baseline in UACR compared to placebo(up to 8 weeks)
- Change from baseline in Systolic Blood Pressure and Diastolic Blood Pressure within group.(up to 8 weeks)
- Plasma concentrations of MT-3995 and its major metabolite(up to 16 weeks)
研究者
研究点 (1)
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