NCT01184599Unknown4 期
A Prospective Study of the Kidney Protective Effect of Aliskiren in Hypertensive Patients With IgA Nephropathy
适应症
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- Renal function (Creatinine clearance)
研究概览
简要总结
The purpose of this study is to evaluate the effect of aliskiren, a novel direct rennin inhibitor, on renal function and progress of renal disease in hypertensive patients with IgA nephropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IgA nephropathy confirmed by renal biopsy
- •Hypertension (<= 125/75 mmHg)
排除标准
- •Patients who have been treated with angiotensin type 1 receptor blocker or angiotensin-converting enzyme inhibitor within 4 weeks
- •Severe hypertension (<= 180/110 mmHg) or secondary hypertension
- •Patients with history of allergy or adverse effect for aliskiren
- •Renal dysfunction (estimated Glomerular Filtration Rate < 60 mL/min/1.73m2)
- •Pregnancy
- •Patient treated with cyclosporine
- •Hyperkalemia (serum potassium >= 5.6 mmol/L)
- •Autoimmune disease including systemic lupus erythematosus
- •Patients inadequate for the study
结局指标
主要结局
Renal function (Creatinine clearance)
时间窗: One year (every 6 months)
Urinary protein
时间窗: One year (every 6 months)
次要结局
- Urinary type 4 collagen(One year (every 6 months))
- Urinary Transforming growth factor-beta(One year (every 6 months))
- Urinary angiotensinogen(One year (every 6 months))
- High-sensitivity C-reactive protein(One year (every 6 months))
- Plasma Rennin Activity(One year (every 12 months))
- Aldosterone(One year (every 12 months))
- Asymmetric dimethylarginine(One year (every 12 months))
- Advanced glycation end product(One year (every 12 months))
- (Pro)renin receptor(One year (every 12 months))
- Oxidative stress(One year (every 12 months))
研究者
研究点 (8)
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