跳至主要内容
临床试验/NCT01093781
NCT01093781撤回不适用

A Pilot Study to Evaluate the Antiproteinuric Effect of Renin Inhibition With Aliskiren in Patients With Idiopathic Membranous Nephropathy

Mayo Clinic1 个研究点 分布在 1 个国家开始时间: 2010年11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
撤回
发起方
Mayo Clinic
试验地点
1
主要终点
Urine protein excretion

研究概览

简要总结

The goal of this proposal is to conduct a pilot study to access the antiproteinuric effect of aliskiren in patients with idiopathic membranous nephropathy. Patients will be treated for 3 months with aliskiren aiming to achieve the maximum tolerated dose and blood pressure (>100 but <125 mmHg systolic BP >75% of the readings).

详细描述

In patients with nephrotic syndrome, including patients with membranous nephropathy (MN), conservative therapy consists of restricting dietary protein intake, and controlling blood pressure (target blood pressure is ≤ 125/75 mmHg), hyperlipidemia, and edema. Angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin II receptor blockers (ARB) are effective anti-hypertensive agents that can reduce proteinuria and slow progression of renal disease in both diabetic and nondiabetic chronic nephropathy patients and for these reasons they are the preferred agents to treat hypertension in proteinuric renal diseases.

Recent studies suggest that renin inhibition with aliskiren may be renoprotective and reduce proteinuria in patients with type 2 diabetes. Similar observations have also been reported in patients with membranous nephropathy and proteinuria in the range of 1-3 g/24h. These observations suggest that aliskiren may have powerful antiproteinuric. However, it is important to emphasize, that none of the patients in these studies had proteinuria greater than 3.0 g/24h. Thus, the antiproteinuric effect of aliskiren in patients with heavy proteinuria (e.g. >4g/24h) is unknown.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Aliskiren

Experimental

Aliskiren dose will begin with 150mg per day and later up-titrated to the maximum available dose of 300mg per day.

干预措施: Aliskiren (Drug)

结局指标

主要结局

Urine protein excretion

时间窗: one year

Urine protein excretion at 12 weeks of renin inhibition with aliskiren

次要结局

  • Blood pressure control; tolerability and side effects(one year)

研究者

发起方
Mayo Clinic
申办方类型
Other

研究点 (1)

Loading locations...

相似试验

Aliskiren in Patients With Idiopathic Membranous... | 临床试验