NCT01203007Unknown不适用
A Pilot Study of 6 Months Diet Intervention in Food Sensitive Patients With IgA Nephropathy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Proteinuria
研究概览
简要总结
The purpose of this study is to assess whether a tailored diet, eliminating antigens to which IgA nephropathy patients have demonstrated sensitivity, will have an effect on proteinuria, renal function and other immunological variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Above 18 years
- •IgA nephropathy (IgAN), verified by biopsy
- •Proteinuria > 1 g/24 h
- •Having signed informed consent form
排除标准
- •Participation in another clinical trial
- •Patients with celiac disease
- •Introduction of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blockers (ARB) during the last three months prior to inclusion
- •Patients treated with immunosuppressive or systemic corticosteroid drugs within the last twelve months
结局指标
主要结局
Proteinuria
时间窗: 6 months
次要结局
- Renal function(6 months)
- IgA/IgG immune complexes, incl. glycosylation(6 months)
- IgA/IgG to dietary antigens(6 months)
- Hematuria(6 months)
研究者
研究点 (3)
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