NCT00437463已完成3 期
Treatment of Early Immunoglobulin A Nephropathy by ACE Inhibitor - a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Development of hypertension (defined as blood pressure above 140/90 mm Hg and require anti-hypertensive therapy)
研究概览
简要总结
To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA nephropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •biopsy-confirmed IgA nephropathy
- •proteinuria less than 0.5 g per day, normal blood pressure, and serum creatinine below 120 µmol/l
排除标准
- •pregnant or nursing mother, or women of childbearing potential without an effective method of birth control
- •history of myocardial infarction, congestive heart failure, or any other medical indication that necessitate the use of ACE inhibitor
- •evidence of clinically significant hepatic, gastrointestinal, autoimmune disease
- •history of malignancy, drug or alcohol abuse
- •participation in any previous trial on ACE inhibitor
- •taking other investigational drugs within the past 30 days
- •known history of sensitivity / allergy to ACE inhibitor
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
Ramipril
干预措施: Ramipril (Drug)
结局指标
主要结局
Development of hypertension (defined as blood pressure above 140/90 mm Hg and require anti-hypertensive therapy)
时间窗: From the beginning to the end of the study
Development of proteinuria
时间窗: From the beginning to the end of the study
20% decline in creatinine clearance, as determined by 24-hour urine collection or estimated by the Gault-Cockroft equation
时间窗: From the beginning to the end of the study
body weight, blood pressure, pulse
时间窗: From the beginning to the end of the study
Adverse effects of treatment
时间窗: From the beginning to the end of the study
次要结局
未报告次要终点
研究者
研究点 (1)
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