跳至主要内容
临床试验/NCT00498537
NCT00498537已完成不适用

Spironolactone for Reducing Proteinuria in Diabetic Nephropathy

US Department of Veterans Affairs1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2003年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
reduction in proteinuria

研究概览

简要总结

Introduction: Aldosterone seems to have deleterious effects on the kidneys. Many animal studies and few clinical trials now have shown that suppression of aldosterone by aldosterone receptor blockers ameliorated these effects.

Method: In a double-blind, cross over study, 24 patients with diabetic nephropathy who were already receiving either ACE inhibitor(lisinopril 20-40 mg/day ) or ARB( losartan 25-100 mg/day )were given spironolactone( 25 mg during the first month and 50 mg during the second and third month if serum K remained ok) or matching placebo with 1 month of washout in between. All patients were from a single center and exclusively male veterans. Blood pressure, serum creatinine, serum K and spot urine protein/creatinine were measured at the beginning and end of each study period. The study was started in May of 2003 and completed in May 2006.

详细描述

Spironolactone for reducing proteinuria and progression of renal failure in diabetic nephropathy

Introduction:

Diabetic nephropathy is the leading cause of ESRD in USA now and accounts for 40% of all new patients that begins renal replacement therapy each year. The number of new patients starting chronic dialysis therapy is 70,000 each year and is increasing. This number does not include patients who decline dialysis therapy or die soon after starting dialysis. The economic and human cost of diabetic nephropathy is therefore enormous.

Aggressive control of blood pressure especially with ACE-inhibitor had been shown to reduce proteinuria and progression of renal dysfunction in both type 1 and type 2 diabetics. Use of ACE-inhibitor reduced proteinuria even in normotensive diabetics with microalbuminuria. However even with optimal use of ACE-Inhibitor the progression of renal dysfunction is not completely stopped. Other additional treatment strategies therefore need to be explored.

Studies in animals and small pilot studies in humans have shown that nondihydropyridine calcium channel blockers (e.g. diltiazem or verapamil) may have additional protective effect in reducing proteinuria when used in conjunction with ACE-inhibitor. Use of angiotensin receptor blockers along with ACE-inhibitors also had been tried but results are not dependable because of the short sample size.

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
Double

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The study is completed. Inclusion criteria was diabetic nephropathy

排除标准

  • Scr >2 mg/dl and serum K > 5meq/L

研究组 & 干预措施

1

Other

干预措施: spironolactone (Drug)

2

Other

干预措施: spironolactone (Drug)

结局指标

主要结局

reduction in proteinuria

次要结局

  • Changes in GFR and incidence of hyperkalemia

研究者

申办方类型
Fed

研究点 (1)

Loading locations...

相似试验