Chinese Observational Prospective Study of Aging Population With Chronic Kidney Disease(C-OPTION)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,000
- 主要终点
- Death
研究概览
简要总结
The study is an observational, multicenter, prospective cohort study aimed at evaluating a 5-year screening programme for chronic kidney disease(CKD) in a population of elderly patients, aged 65 years or more, in China.To analyze the etiology and composition spectrum, the incidence of complications and co-morbidities.To assess the correlation between daily living ability, mental and physical function, quality of life, nutritional status and prognosis.To develop biomarkers of renal aging.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age≥65 years
- •clinical diagnosis of CKD
- •signed informed consent
排除标准
- •subjects who have a poor compliance and cannot be scheduled for follow-up
- •subjects participating in other interventional clinical trials
- •ESRD or dialysis
- •Acute kidney injury(AKI)
- •history of solid organ or bone marrow transplantation
- •active malignancy within 24 months prior to screening or metastatic cancer
- •life expectancy less than 6 months；
- •severe cognitive impairment（NYHA III or IV）
- •HIV infection or AIDS
- •subjects cannot be able to complete the assessment including dementia or other mental disorders, limited physical activity, severe visual impairment
- •simple hematuria
结局指标
主要结局
Death
时间窗: 5 year
Incidence of End Stage Renal Disease (ESRD)
时间窗: 5 year
ESRD will be defined as estimated glomerular filtration rate(eGFR)\<15 mL/min/1.73 m2 or dialysis
eGFR decline≥40%
时间窗: 5 year
次要结局
- Heart failure(5 year)
- Acute coronary syndrome(5 year)
- Peripheral arterial disease(5 year)
- Cerebral stroke(5 year)
研究者
Chen Xiangmei
Academician of Chinese Academy of Engineering
Chinese PLA General Hospital