NCT00922311已完成4 期
Aliskiren Combined With Losartan in Immunoglobulin A Nephropathy: an Open-label Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change of urine protein excretion rate
研究概览
简要总结
Study objective: To investigate the potential anti-proteinuric efficacy of aliskiren, a novel direct renin inhibitor (DRI), in addition to angiotensin receptor blocker (ARB) in immunoglobulin A nephropathy (IgAN) patients at risk of developing progressive renal failure.
详细描述
This will be an open-label pilot study in which IgAN patients with persistent proteinuria despite maximum dose of ARB treatment will be assigned to receive Aliskiren. There is the optional addition of other anti-hypertensive agents to achieve an optimal target blood pressure of <130/80 mmHg.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 - 70 years of age
- •Histologic diagnosis of IgA nephropathy
- •Proteinuria > 1 g/day or UPC > 1 mg/mg or 113 mg/mmol at least twice
- •Receiving treatment with the maximum dose of ARB for at least 3 months
- •Patients who are willing to give written, informed consent
排除标准
- •eGFR < 15 ml/min/1.73 sq.m
- •UPC >5000 mg/g or 570 mg/mmol, or <500 mg/g or 57 mg/mmol
- •Serum K+ > 5.2 mmol/L
- •Presence of bilateral renal artery stenosis
- •Presence of diabetes mellitus
- •Renal histology showing pathologies other than IgAN
- •Known allergy to ARB or DRI
- •Patients on ARB/ACEi combination within 12 weeks of randomization
- •Concurrent treatment with corticosteroids, Nsaid, or immunosuppressant
- •Patients with connective tissue disease or obstructive uropathy
- •Patients with malignancy or conditions severely limiting life expectancy
- •Female who are pregnant or intending to conceive
- •Female of child-bearing age unwilling to practice contraception
- •Patients who are unable to give informed consent
- •Patients simultaneously participating in another study
研究组 & 干预措施
Aliskiren
Experimental
干预措施: Aliskiren (Drug)
结局指标
主要结局
Change of urine protein excretion rate
时间窗: 6 months
次要结局
- Changes in serum creatinine, eGFR, serum potassium and albumin(6 months)
研究者
研究点 (2)
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