The Change of Urinary Angiotensinogen Excretion After Valsartan Treatment in Chronic Kidney Diseases Patients With Persistent Proteinuria
试验速览
- 阶段
- 4 期
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The percent change of urinary angiotensinogen excretion between at baseline and at 24 weeks after valsartan treatment.
研究概览
简要总结
This study is a multicenter, prospective, interventional study. It does not have a control group. All participants will receive 160 mg valsartan for 8 weeks. Among them, the patients with persistent proteinuria (defined as proteinuria more than 1 g/g after 8 weeks treatment of valsartan) will receive 320 mg valsartan for further 16 weeks. Participants who did not receive any ACEI or ARB previously will have a titration period for 4 weeks (80 mg for 4 weeks, 160 mg for 4 weeks, and then 320 mg for 16 weeks).
The investigators will evaluate the change of urinary angiotensinogen excretion between at baseline, at 8 weeks, and 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Chronic kidney disease patients with
- •proteinuria of 1 - 10 g/day,
- •stable and controlled blood pressure (100/60 mmHg - 160/100 mmHg),
- •stable renal function with GFR ≥ 30 mL/min/ m2,
- •diabetes or non-diabetes
排除标准
- •Uncontrolled diabetes (defined as HbA1c > 9.0%)
- •Immunosuppressive treatment within 6 months
- •Intractable edema
- •Hyperkalemia (>5.5 mEq/L) or Hypokalemia (< 3.5 mEq/L)
研究组 & 干预措施
valsartan
干预措施: valsartan (Drug)
结局指标
主要结局
The percent change of urinary angiotensinogen excretion between at baseline and at 24 weeks after valsartan treatment.
时间窗: 4 weeks of screening periods + 24 weeks of treatment
次要结局
未报告次要终点