A Crossover Pilot Study of the Effect of Amiloride on Proteinuria in Patients With Proteinuric Kidney Disease
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 24 hr urine protein excretion
研究概览
简要总结
This cross-over study is designed to test the hypothesis that amiloride will reduce urinary protein excretion and protect the kidney from rapid progression in proteinuric kidney disease.
详细描述
Patients with proteinuric kidney disease will be enrolled and receive either amiloride or triamterene first, a similar diuretic acting on epithelial sodium channel (ENaC) as amiloride, but not inhibiting urokinase plasminogen activator receptor (uPAR), will be used as a control. Then patients will cross over to receive another medication. We postulate that amiloride could be beneficial in the patients with proteinuric kidney diseases and could be used as an adjunct therapy to reduce proteinuria and to delay renal disease progression in this patient population.
Specific Aim 1: To examine the effects of amiloride on 24 hour urine protein excretion in patients with proteinuric kidney diseases.
Specific Aim 2: To study if the effect of amiloride on proteinuria reduction is mediated by suppressing soluble urokinase plasminogen activator receptor (suPAR) expression.
Study Design:
The study includes 3 phases. 30 patients will be recruited to this study. All patients need to be on an angiotensin converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) daily at least two month prior to the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with any type of proteinuric kidney diseases
- •Aged 18-75
- •Proteinuria ≥1g/day
- •estimated glomerular filtration rate (eGFR) ≥ 30ml/min/1.73m2
排除标准
- •Clinical evidences of lupus nephritis, or HIV associated nephropathy
- •eGFR <30ml/min/1.73m2
- •Requirement for treatment with mineralocorticoid receptor antagonists (spironolactone, eplerenone)
- •Status post kidney transplant
- •Received glucocorticoid steroids within six months
- •Serum K >4.8 mmol/L
- •Total carbon dioxide <17 mmol/L
- •Hemoglobin <10 g/dl
- •Contraindicated or allergic to loop diuretics or potassium sparing diuretics
- •Abnormal liver function tests
研究组 & 干预措施
Amiloride Phase
Subject receives 5mg of Amiloride twice daily for 8 weeks.
干预措施: Amiloride (Drug)
Triamterene Phase
Subject receives 50mg of Triamterene twice daily for 8 weeks.
干预措施: Triamterene (Drug)
结局指标
主要结局
24 hr urine protein excretion
时间窗: 20 weeks
Identify changes in 24 hr urine protein excretion throughout the 3 phases of the study.
次要结局
- serum suPAR concentration(20 weeks)
- urine plasmin activity(20 weeks)
- urine plasminogen activity(20 weeks)
- urine suPAR concentration(20 weeks)
研究者
Wen Shen, MD, PHD
Associate Professor of Medicine
Georgetown University