Multicenter Cohort Study of ANCA-associated Small Vasculitis in Hunan Province of China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Death
研究概览
简要总结
This study aimed to explore the incidence of Anti-neutrophil cytoplasmic antibody (ANCA）-associated vasculitis (AAV) progression and its association with adverse consequences. It will enroll approximately 500 AAV patients in Hunan province of China and follow-up for at least 5 years. Demographic characteristics, clinical and laboratory data will be collected at baseline and every follow-up. The principal clinical outcomes of the study consist of end stage renal disease (ESRD) and death.
详细描述
The study is a multicenter prospective cohort study, aimed to explore the incidence of AAV and its progression and association with adverse consequences. The study will establish a baseline cohort of 500 AAV patients in Hunan province of China. The follow-up will be conducted for at least 5 years until death or starting renal replacement therapy or dropout. Their demographic characteristics, clinical data, laboratory and imaging examinations will be collected at baseline and every follow-up.
The baseline visit includes the following items: detailed demographics, medical and family history, medication history, health behaviors, physical activity, and anthropometric measures. The laboratory parameters of chemistry test. After the baseline visit, participants will return annually for follow-up visits and evaluation. The evaluating items of follow-up visits are similar to the baseline visit, and sample collection.
The principal clinical outcomes of the study can be broadly categorized as end stage renal disease and death. Death is further clarified as cardiac, infectious, renal, others, or unknown.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfill 2012 criteria of ANCA associated vasculitis and agree to sign informed consent
排除标准
- •Do not agree to sign informed consent
结局指标
主要结局
Death
时间窗: from date of baseline examination until the date of death from any cause, up to 60 months
death from any cause
End stage renal disease or significant loss of renal function
时间窗: from date of baseline examination until the date of first documented end stage renal disease or date of death from any cause, whichever came first, up to 60 months
start of chronic dialysis or renal transplantation or irreversible development of glomerular filtration rate \<15 ml/minute per 1.73m(2)
次要结局
- Adverse events(Five years)
- Disease activity(Five years)
研究者
Xiangcheng Xiao
Professor
Xiangya Hospital of Central South University