NCT00768638已完成4 期
The Renal Protective Effects of Low-dose and High-dose Atorvastatin in Patients With Glomerular Disease and Proteinuria: a Randomized Controlled Double Blinded Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- proteinuria
研究概览
简要总结
Randomized controlled double blind study of parallel groups to evaluate the comparative effects of low-dose of atorvastatin on proteinuria in patients with stage 3 or 4 chronic kidney disease.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 and over
- •Stage 3 or 4 chronic kidney disease (modified MDRD)
- •proteinuria of > 1g/d on ACEi and/or ARB, or proteinuria of > 1g/d with intolerance or contraindication to ACEi and/or ARB
- •blood pressure < 130/80 mmHg or < 140/90 mmHg in patients with five or more antihypertensive drugs
- •stable renal function
排除标准
- •rapid progression of renal failure
- •immunosuppressive therapy within the past 3 months
- •need a renal replacement therapy within 8 months
- •definite history of chronic liver disease, or abnormal liver function
- •evidence of active inflammatory muscle disease
- •definite previous adverse reaction to a statin
- •concurrent treatment with a contraindicated drug (fibrate, macrolide antibiotic, systemic use of imidazole or triazole antifungals, protease-inhibitors, ciclosporin)
- •child bearing potential
- •known to be poorly compliant with clinic visits or prescribed medication
研究组 & 干预措施
Atorvastatin 10mg
Active Comparator
干预措施: Atorvastatin (Drug)
Atorvastatin 40mg
Active Comparator
干预措施: Atorvastatin (Drug)
结局指标
主要结局
proteinuria
时间窗: 6 months
次要结局
未报告次要终点
研究者
Karine Marquis
Professionnelle de recherche
Laval University
研究点 (1)
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