ISRCTN47722295进行中（未招募）4 期
An open-label study evaluating the efficacy and safety of budesonide in the treatment of patients with immunoglobulin A nephropathy
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
研究概览
简要总结
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37978255/ (added 20/11/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged =18 years
- •2. Patients with a histological diagnosis of IgA nephropathy
- •3. Patients with primary IgA nephropathy
- •4. Patients with persistent proteinuria over 1g/day despite adequate renin-angiotensin-aldosterone system (RAAS) blockade or patients with proteinuria between 0.5 and 1 g/day after RAAS blockade if they had additional risk factors for progression (estimated glomerular filtration rate below 60 ml/min/1.73m², presence of proliferative lesions on kidney biopsy)
排除标准
- •1. IgAN associated with other disorders (viral infections, autoimmune disorders, malignancy)
- •2. Estimated glomerular filtration rate below 20 ml/min/1.73m²
- •4. Nephrotic syndrome or a rapidly progressive clinical course
- •5. Proteinuria below 0.5 g/day after adequate RAAS blockade.
- •6. Severe histological lesions of activity or chronicity (endocapillary hypercellularity in over 50% of examined glomeruli, crescents in over 30% of examined glomeruli, presence of fibrinoid necrosis, global glomerulosclerosis in over 50% of examined glomeruli)
- •7. Diabetes mellitus or active infections
- •8. Received prior immunosuppression
研究者
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