NCT00338091终止不适用
Long-Term Renoprotection of Optimal Antiproteinuric Doses of Benazepril and Losartan in Chronic Renal Insufficiency
Southern Medical University, China1 个研究点 分布在 1 个国家开始时间: 2002年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 试验地点
- 1
- 主要终点
- The primary efficacy measure was the time to the first event of the composite endpoint of a doubling of the serum creatinine concentration, ESRD or death.
研究概览
简要总结
The primary goal of the trial was to evaluate whether the optimal antiproteinuric doses of benazepril (an ACE inhibitor) or losartan (an ARB), as compared with their conventional doses, can safely improve the long-term renal outcome in nondiabetic patients with proteinuria and chronic renal insufficiency. The second aim was to compare the long-term renal protection between benazepril and losartan at similar clinical setting.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Serum creatinine concentration of 1.5 to 5.0 mg per deciliter (133 to 442 µmol/L)
- •Creatinine clearance of 20 to 70 ml per minute per 1.73m2, with variations of less than 30 percent in the three months before screening evaluation
- •nondiabetic renal disease
- •Persistent heavier proteinuria (defined by urinary protein excretion of more than 1.0 g per day for three or more months without evidence of urinary tract infection or overt heart failure [a New York Heart Association class of Ⅲ or Ⅳ])
排除标准
- •Immediate need for dialysis
- •Treatment with corticosteroids, non steroidal anti-inflammatory drugs, or immunosuppressive drugs
- •Hyper-or hypokalemia (serum potassium concentration 5.6 mmol per liter or more，or 3.5 mmol per liter or less)
- •Renovascular disease
- •Myocardial infarction or cerebrovascular accident in the year preceding the trial
- •Connective-tissue disease; and obstructive uropathy
结局指标
主要结局
The primary efficacy measure was the time to the first event of the composite endpoint of a doubling of the serum creatinine concentration, ESRD or death.
次要结局
- Secondary endpoints included changes in urinary protein excretion rate and the progression of renal disease assessed by creatinine clearance and glomerular filtration rate as calculated by Modification of Diet in Renal Disease equation-4.
研究者
研究点 (1)
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