NCT01758120Unknown4 期
A Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- the changes of kidney function or death
研究概览
简要总结
Treatment of prednisone plus cyclophosphamide may be superior to treatment of prednisone alone in patients with advanced-stage IgA nephropathy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •biopsy-proven primary IgA nephropathy;
- •18-70 years old;
- •elevated serum Creatinine and less than 3.0mg/dl;
- •with a written consent from participants to receive prednisone and/or cyclophosphamide
排除标准
- •diabetes;
- •contraindications for the treatment of prednisone and/or cyclophosphamide;
- •any treatment with steroids or immunosuppressive drugs prior to this study;
- •acute deterioration of renal function(including those of glomerular origin)
研究组 & 干预措施
prednisone plus cyclophosphamide
Experimental
prednisone plus cyclophosphamide: prednisone(0.5mg/kg/day*6 months) plus cyclophosphamide(1g intravenous use,per 1 month*6months)
干预措施: prednisone plus cyclophosphamide (Drug)
prednisone alone
Experimental
prednisone alone: prednisone(0.5mg/kg/day*6 months)
干预措施: Prednisone alone (Drug)
结局指标
主要结局
the changes of kidney function or death
时间窗: 3,6 ,12, 24 and 36 months or more after treatment
the changes of estimated glomerular filtration rate (eGFR) or a combination of reaching end-stage renal disease (ESRD) or doubling of serum Creatinine or death
次要结局
- the changes of proteinuria(3,6 ,12, 24 and 36 months or more after treatment)
研究者
Wei Shi
clinical professor
Guangdong Provincial People's Hospital
研究点 (1)
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