NCT00212901已完成不适用
Addition of Angiotensin Receptor Blockade to ACE Inhibition Versus High Dose ACE Inhibition for Reduction of Proteinuria in Patients With Diabetic Nephropathy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- reducing proteinuria
研究概览
简要总结
Investigation of wheather addition of angiotensin receptor blocker (Irbesartan) to recommended doses of angiotensin converting enzyme inhibitor (trandolapril) is more effective in decreasing amount of protein in urine in patients with diabetic kidney disease than high doses of trandolapril.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
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
- •Early diabetic nephropathy as defined by proteinuria between 500mg/24hr and 3g/24hr and GFR>50ml/min (as calculated by the Cockcroft-Gault formula), in the absence of clinical and laboratory evidence of other non-diabetic renal disease.
- •Controlled blood pressure (<150/<90)
- •Able to give informed consent
- •Between the ages of 18 and 75
- •Must be capable of providing a 24 hour urine collection
- •Negative BHcG test for ruling out pregnancy in women of childbearing age
- •Currently taking an angiotensin converting enzyme inhibitor
排除标准
- •Creatinine clearance <50ml/min or 24hour protein excretion >3gm/d.
- •Hypotension as defined by the inability to add an ARB or increase ACE-I dose secondary to hypotensive symptomatology or a systolic Bp <100mmHg.
- •Serum potassium >5.5 on two separate occasions in the previous six months
- •Previous adverse reaction to angiotensin receptor antagonist medication
- •Use of NSAIDS including COX2 inhibitors
- •Pregnant or nursing women will be excluded
- •Currently taking an angiotensin receptor antagonist
结局指标
主要结局
reducing proteinuria
次要结局
- glomerular filtration rate
- side-effects of hypotension, postural symptom
研究者
研究点 (2)
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