Phase 4 Study of the Efficacy of Pentoxifylline in Patients With Chronic Kidney Disease Receiving Angiotensin Receptor Blockade
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- spot urinary proteinuria between groups
研究概览
简要总结
To study whether pentoxifylline has additive renoprotective effect in patients taking ARB
详细描述
In patients with CKD and serum creatinine 1.3~6.0 md/gl, having taken losartan 100 mg/day for at least 3 months, with stable renal function, will be recruited to a randomized open-label trial. Patients taking pentoxifylline or not will be compared for their spot urinary proteinuria, estimated glomerular filtration, spot urine tumor necrosis factor-α/creatinine ratio, spot urine monocyte-chemoattractant protein-1/creatinine, and aldosterone concentration between groups in a 2-year study. Add-on pentoxifylline in control group in the same dose as in treat group will be performed to observe the renoprotective effect if any protective potential is demonstrated in the end of maintenance 12 months.
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
- 20 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 with serum creatinine 1.3~6.0 mg/dl
排除标准
- •History of allergy to pentoxifylline
- •Females are nursing or pregnant
- •Obstructive uropathy
- •Unable to stop chronic immunosuppressive therapy, NSAID
- •Congestive heart failure (New York Heart Association functional class III or IV)
- •Unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, within the past 6 months prior to signing the informed consent form
- •Cerebral hemorrhage within the past 6 months prior to signing the informed consent form
- •Retinal hemorrhage within the past 6 months prior to signing the informed consent form
- •Known or suspected secondary hypertension (e.g., primary aldosteronism, renovascular hypertension, pheochromocytoma)
- •Severe uncontrolled hypertension with SBP > 220 mmHg and/or DBP > 115 mmHg
- •Hepatic dysfunction as defined by the following laboratory parameters: ALT or AST > 2 times the upper limit of the normal range
- •Biliary obstructive disorders (e.g. cholestasis)
- •Active malignancy
结局指标
主要结局
spot urinary proteinuria between groups
次要结局
- estimated glomerular filtration, spot urine tumor necrosis factor-α/creatinine ratio, spot urine monocyte-chemoattractant protein-1/creatinine, and aldosterone concentration between groups.