The Effect of Aldosterone Inhibition on Proteinuria in Patients With Progressive Renal Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Proteinuria reduction
研究概览
简要总结
The purpose of this study is to examine whether the inhibition of aldosterone will result in lower excretion of protein via urine. The hypothesis is that if loss of protein is lowered, progression of renal disease with be slower than otherwise expected.
详细描述
Patients with chronic renal disease are likely to progress to end stage renal disease with the need for renal replacement therapy. It is accepted that proteinuria is a surrogate measurement for progression. If proteinuria can be lowered we hope to prolong patients pre-dialysis phase. Our theory is that aldosterone inhibition will lead to this.
For a period of 8 weeks patients will be randomized to either aldosterone receptor inhibition with the drug eplerenone or control without. Blood pressures will be kept at the same level using other drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proteinuria > 500 mg/24 hours
- •Hypertension or anti-hypertensive treatment
排除标准
- •Diabetic nephropathy
- •GFR< 20 ml/min
- •P-potassium between 3,5 mmol/l and 5,0 mmol/l
研究组 & 干预措施
1
Eplerenone
干预措施: Eplerenone (Drug)
2
Control
干预措施: Eplerenone (Drug)
结局指标
主要结局
Proteinuria reduction
时间窗: bi-monthly
次要结局
- Evaluating blood pressure response and hyperkalaemia after aldosterone inhibition.(weekly)
研究者
Lene Boesby
MD
Herlev Hospital