NCT02517320已完成2 期
A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety 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
- 293
- 试验地点
- 1
- 主要终点
- Change form baseline in UACR
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of MT-3995 in subjects with diabetic nephropathy, compared with placebo, using urine albumin- to-creatinine ratio (UACR) in the first morning void urine sample as an indicator.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Type 2 diabetes mellitus
- •Glycated hemoglobin(HbA1c) values (National Glycohemoglobin Standardization Program : NGSP) ≤10.5%
- •estimated glomerular filtration rate(eGFR) of ≥30 mL/min/1.73 m2
- •The median UACR of the first morning void urine samples is ≥50 mg/g Cr and <300 mg/g Cr
- •Stable blood pressure(diastolic blood pressure (DBP) <100 mmHg and stable systolic blood pressure (SBP) <160 mmHg)
排除标准
- •Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes.
- •A diagnosis of non-diabetic renal disease.
- •A following serum potassium level.
- •eGFR of 30-59mL/min/1.73m2; serum potassium level of <3.5 or >4.7 mmol/L,
- •eGFR of ≥60mL/min/1.73m2: serum potassium level of <3.5 or >5.0 mmol/L
- •symptomatic and clinically significant hypotension(diastolic blood pressure(DBP)<50mmHg and systolic blood pressure(SBP)<110mmHg)
- •QT prolongation or torsades de pointes, or, a history or family history of QT prolongation or torsades de pointes
- •New York Heart Association (NYHA) Class III or IV heart failure
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)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change form baseline in UACR
时间窗: Week 24
次要结局
- Change in renal function(From baseline to 24 weeks)
- Change in serum potassium(From baseline to 24 weeks)
- Change in UACR classification(From baseline to 24 weeks)
- Adverse events(From baseline to 24 weeks)
研究者
研究点 (1)
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