Sympathetic Nervous System Inhibition for the Treatment of Diabetic Nephropathy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Urine albumin/creatinine ratio (UACR)
研究概览
简要总结
The purpose of this study is to determine whether moxonidine is effective in reducing urine albumin levels in patients with diabetic kidney disease.
详细描述
This study will investigate the effect of moxonidine in lowering urine albumin excretion and limiting further damage to the kidneys in patients with diabetic nephropathy. Reducing urine albumin excretion in type 2 diabetic patients is an indicator of successful treatment. Previous studies have shown that drugs that work in a similar fashion to moxonidine (intervene with the sympathetic nervous system)have been very effective in reducing the amount of albumin in the urine and are associated with long term renal and cardiovascular protection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •age: 18-75 years
- •diabetic nephropathy as defined by the mean of three consecutive early morning urinary albumin-creatinine ratios (UACR) of >300mg per gram, or > 200mg per gram in patients receiving therapy targeted at blockade of the RAS
排除标准
- •non-diabetic kidney disease
- •UACR of more than 3500mg per gram, an estimated glomerular filtration rate of less than 30ml/min/1.73m
- •chronic urinary tract infection.
- •severe hypertension
- •heart failure New York Heart Association (NYHA) class II-IV
- •major cardiovascular disease within the previous 6 months
- •left ventricular ejection fraction <55%
研究组 & 干预措施
Moxonidine
干预措施: Moxonidine (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Urine albumin/creatinine ratio (UACR)
时间窗: 12 weeks
The primary outcome measure is the difference in the change of UACR between active treatment and placebo from baseline to week 12 of treatment.
次要结局
- muscle sympathetic nerve activity (MSNA)(12 weeks)