NCT05510323招募中3 期
Efficacy and Safety of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 Chronic Kidney Disease
Air Force Military Medical University, China1 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2024年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Combined event
研究概览
简要总结
The purpose of this clinical trial is to evaluate the long-term efficacy and safety of low-dose oral corticosteroids combined with cyclophosphamide therapy and low-dose corticosteroids monotherapy, on a background of maximal RAS inhibitor therapy, for IgA nephropathy with stage 3 or 4 chronic kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Biopsy-proven IgA nephropathy;
- •Proteinuria ≥1.0g/day while receiving maximum tolerated dose of RAS blockade;
- •Estimated glomerular filtration rate 15-60 ml/min/1.73/m2.
排除标准
- •Indication or contraindication for immunosuppressive therapy with corticosteroids
- •Use of corticosteroids and other immunosuppressive drugs within the last 1 year
- •Current unstable kidney function for other reasons
- •Under 18 years old
- •Patients with secondary IgAN
- •Patients who are unlikely to comply with the study protocol in the view of the treating physician
研究组 & 干预措施
CS
Active Comparator
low-dose corticosteroids monotherapy
干预措施: Prednisolone (Drug)
CS+CTX
Active Comparator
low-dose corticosteroids combined with cyclophosphamide
干预措施: Prednisolone plus Cyclophosphamide (Drug)
结局指标
主要结局
Combined event
时间窗: up to 6 years
40% decrease in eGFR, ESRD or death due to kidney disease
次要结局
- 30% decrease in eGFR(up to 6 years)
- ESRD(up to 6 years)
- All cause death(up to 6 years)
- Proteinuria remission at 6, 12 months and total follow-up period(up to 6 years)
- Hematuria remission at 6, 12 months and total follow-up period(up to 6 years)
- The composite of 30% decrease in eGFR, ESRD and all cause death(up to 6 years)
- The composite of 50% decrease in eGFR, ESRD and all cause death(up to 6 years)
- Annual eGFR decline rate(up to 6 years)
- The composite of 40% decrease in eGFR, ESRD and all cause death(up to 6 years)
- 40% decrease in eGFR(up to 6 years)
- 50% decrease in eGFR(up to 6 years)
研究者
Shiren sun
Chief
Air Force Military Medical University, China
研究点 (1)
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