The Safety and Short-Term Efficacy of Aliskiren in the Treatment of Immunoglobulin A Nephropathy - A Randomized Cross-Over Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- change in the degree of proteinuria
研究概览
简要总结
Immunoglobulin A (IgA) nephropathy is the most common type of primary glomerulonephritis in the world. Current treatment with angiotensin converting enzyme (ACE) inhibitor and angiotensin receptor blocker (ARB) is not entirely effective. Aliskiren, a direct renin inhibitor, acts on the rate limiting step of the renin-angiotensin axis. In addition to lowering the blood pressure, recent study in diabetic nephropathy suggests an independent anti-proteinuric effect. The investigators plan to conduct a randomized placebo-control cross-over study to evaluate the safety and efficacy of aliskiren in the treatment of IgA nephropathy. The investigators plan to recruit 57 patients with biopsy-proven IgA nephropathy and persistent proteinuria despite conventional therapy. They will be randomized to aliskiren for 16 weeks or no treatment, followed by cross over to the other arm after a washout period. Proteinuria, albuminuria, renal function, serum and urinary markers will be quantified. This study will explore the potential anti-proteinuric effect of aliskiren in the treatment of IgA nephropathy, which has no specific treatment at present.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18-65 years
- •requires anti-hypertensive therapy
- •renal biopsy within the past 3 years and confirmed the diagnosis of IgA nephropathy
- •proteinuria > 1 g/day (or proteinuria > 1 g/g-Cr) in 3 consecutive samples within 12 weeks despite ACE inhibitor or ARB treatment for at least 3 months
- •estimated glomerular filtration rate > 30 ml/min/1.73m2
- •willingness to give written consent and comply with the study protocol
排除标准
- •Patients who are diabetic, and patients with systemic diseases that may cause IgA nephropathy or another nephropathy.
- •Pregnancy, lactating or childbearing potential without effective method of birth control
- •Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication
- •History of malignancy, including leukemia and lymphoma within the past 2 years
- •Systemic infection requiring therapy at study entry
- •Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
- •History of drug or alcohol abuse within past 2 years
- •Participation in any previous trial on aliskiren or other renin inhibitor
- •Previous treatment with fish oil, steroid, cytotoxic agents, or aldosterone antagonist
- •History of treatment with other drugs that may affect proteinuria within past 2 years
- •Patients receiving treatment of corticosteroid
- •On other investigational drugs within last 30 days
- •History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study
- •History of non-compliance
- •Known history of sensitivity or allergy to aliskiren or other renin inhibitor
研究组 & 干预措施
I
each subject will receive oral aliskiren 300 mg/day for 16 weeks, followed by a washout period of 4 weeks, then crossed over to placebo for another 16 weeks
干预措施: Aliskiren (Drug)
I
each subject will receive oral aliskiren 300 mg/day for 16 weeks, followed by a washout period of 4 weeks, then crossed over to placebo for another 16 weeks
干预措施: Placebo (Drug)
II
each subject will receive placebo for 16 weeks, followed by a washout period of 4 weeks, then crossed over to oral aliskiren 300 mg/day for another 16 weeks
干预措施: Aliskiren (Drug)
II
each subject will receive placebo for 16 weeks, followed by a washout period of 4 weeks, then crossed over to oral aliskiren 300 mg/day for another 16 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
change in the degree of proteinuria
时间窗: 16 weeks
次要结局
- rate of decline of estimated GFR(16 weeks)
- change in serum and urinary inflammatory markers(16 weeks)
研究者
Cheuk-Chun SZETO
Professor
Chinese University of Hong Kong