NCT00949351Unknown4 期
Safety of Add on Aliskiren to ACEI and ARB Treatment in Type 2 Diabetes With Nephropathy
Lerdsin General Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Assess short-term safety of the combination of aliskiren 300 mg/valsartan 160 mg /enalapril 20 mg in patients with diabetic nephropathy
研究概览
简要总结
Activation of renin-angiotensin plays a crucial role diabetic nephropathy. Angiotensin converting enzyme inhibitor (ACEI) and Angiotensin I receptor blocker (ARB) has been shown renoprotection whether it was used alone or in combination. Aliskiren is a direct renin inhibitor (DRI) that has shown renal benefits and safety when combined with ARB. However, to date, the safety of add on aliskiren to the combination treatment of ACEI and ARB in diabetic nephropathy patients remains to elucidate.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Type2 diabetes patients
- •Age <30yrs-70yrs>
- •Overt proteinuria (Urinary protein creatinine ratio > 200mg/g 2 times or more during past 6 Mo)
- •Scr < 2.5 mg/dL
- •HbA1C < 7.5
- •Systolic blood pressure > 160 mmHg without antihypertensive drugs or > 140 with antihypertensive drug
- •No history of previous cardiovascular event (Stroke, Myocardial infarction, unstable angina, hospitalization, surgical correction PVD or PVD with claudication)
- •No hospitalization within 1 yr except for elective surgery
排除标准
- •Physical examination found or suspected serious co-morbid (AF, carotid bruit, structural heart disease, cirrhosis and decompensate liver disease)
- •Non adherence to protocol
- •Intolerable to ACEI or ARB during run-in
- •Abnormal liver function test at the run-in period
- •Rapid declining renal function (SCr increase > 40%) during run-in
- •Hyperkalemia (serum K > 5.5 mEq/L at randomization)
- •Malignancy detected o
- •SBP lower than 110 mmHg (at randomization)
研究组 & 干预措施
Aliskiren
Placebo Comparator
干预措施: Aliskiren 300mg/d (Drug)
结局指标
主要结局
Assess short-term safety of the combination of aliskiren 300 mg/valsartan 160 mg /enalapril 20 mg in patients with diabetic nephropathy
时间窗: 12 wk after randomization
次要结局
- Reduction of systolic blood pressure(12 wk after randomization)
- Reduction of proteinuria(12 wk after randomization)
- Change in GFR/mo(12 wk after randomization)
- Change of Serum prorenin level compare to baseline(12 wk after randomization)
- Change of Urinary TGFb1 compare to baseline(12 wk after randomization)
研究者
研究点 (1)
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