Phase 2 Trial of Effect of Combine Pentoxifylline and Captopril on Proteinuria in Diabetic Nephropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- decreasing urinary protein
研究概览
简要总结
Diabetic nephropathy is the most common cause of ESRD and has a great impact on mortality and morbidity of diabetic patients. Despite renoprotective effect of ACE inhibitors in diabetic patients they can not hinder the progression of renal disease completely. Pentoxifylline as a TNFa blocker may hinder progression of diabetic nephropathy in combination of captopril.
详细描述
Diabetic nephropathy is the most common cause of ESRD and has a great impact on mortality and morbidity of diabetic patients. Despite renoprotective effect of ACE inhibitors in diabetic patients they can not hinder the progression of renal disease completely. TNFa is a cytokine that is a target for medical therapy in diabetic nephropathy. In this study the effect of captopril on overt diabetic nephropathy compared to effect of combination of captopril and an antiTNFa drug ( pentoxifylline).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Absence of kidney or urinary tract disease
- •Absence of high blood pressure OR Controlled blood pressure (≤140/90) with medication other than ACE inhibitors and/or non dihydropyridine calcium channel blockers
- •A well controlled blood sugar level (HbA1c≤7.5%)
- •Adhering to the diet protocol for patients with renal disease
排除标准
- •NYHA functional class III, IV
- •Valvular heart disease
- •Unstable angina, myocardial infarction, cerebrovascular accidents
- •Psychiatric disease
- •Prior allograft kidney transplant
- •Acute illness
- •Infectious disease including urinary tract infection
- •Leukocytosis or any febrile illness at enrollment
- •Prior history or development of any form of malignancy
- •History of alcohol or drug abuse or smoking
- •Need for surgery during the study
- •Allergy to derivatives of methyl xanthines
- •Current Pentoxyphilline use
研究组 & 干预措施
A,1,II
patients in this arm takes 25 mg captopril q8h
干预措施: Captopril (Drug)
A,2,II
干预措施: Captopril + Pentoxifylline (Drug)
结局指标
主要结局
decreasing urinary protein
时间窗: 2 and 6 months
次要结局
未报告次要终点