An Extended Follow-up of the Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced Stage IgA Nephropathy
试验速览
- 阶段
- 4 期
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- the changes of kidney function or death
研究概览
简要总结
This study is an extended follow-up of the study (ClinicalTrials.gov ID: NCT01758120)-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
- Triple (Participant, Care Provider, Outcomes Assessor)
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 and cyclophosphamide
- prednisone(0.5mg/kg/day*6 months)
- cyclophosphamide(1g intravenous use,per 1 month*6months);
- supportive care,including ACE-I or ARBs and blood pressure control
干预措施: prednisone and cyclophosphamide (Drug)
prednisone alone
- prednisone(0.5mg/kg/day*6months);
- supportive care,including ACE-I or ARBs and blood pressure control
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: a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)
1. addition of 2-year-follow up to the ClinicalTrials.gov ID: NCT01758120;Time Frame:4 years and 5 years after the initiation of treatment 2. 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(a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120))
- Number of Participants with Adverse Events(a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120))
研究者
Wei Shi
Clinical Professor
Guangdong Provincial People's Hospital