A Real World, Multi-centric, Observational Registry Study of Chronic Kidney Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90,000
- 试验地点
- 8
- 主要终点
- The occurrence of chronic kidney diseases in non-CKD participants
研究概览
简要总结
Chronic kidney disease (CKD) refers to a variety of different diseases characterized by impairment of kidney structure and/or renal function. The prevalence of CKD in China is as high as 10.8%. With a population of more than 150 million, China has the largest number of CKD patients all over the world. People with CKD would not only progress to uremia and need renal replace treatment, it also significantly increases risk of cardiovascular disease than non-CKD population. It has created a heavy burden on people's health and national economy. There is an urgent need to establish an effective system for CKD prevention and control in China. Evidences from large sample cohort and real world based research are still rare. This study will provide good experience for reducing the occurrence and development of CKD.
详细描述
This study is designed as an investigator-initiated, multi-center, prospective and observational real world study based on mainland Chinese population. The investigators aimed to investigate the occurrence, development, treatment, prognosis state and related risk factors of CKD in China.
This study based on the standardized data network, which provides efficient data collection, integration and analysis for researchers and clinicians in multi-centers.
The sample size of this study was estimated by statisticians, epidemiologists and clinicians. Real-world studies adopted an open standard for inclusion and exclusion, larger sample size could cover a wider group of patients and take the possibility of loss of follow-up into account. Subgroup analysis can be performed in a heterogeneous population and expand the significance of the study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with CKD as defined in the KDIGO Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease 2012 Edition;
- •Non-CKD patients with hypertension, diabetes, hyperlipidemia, hyperuricemia, eGFR (CKD-EPI formula) of 60-89 ml/min/1.73m^2 and other risk factors for CKD;
- •Healthy population.
- •Signed the informed consent voluntarily.
排除标准
- •。Patients identified to be unsuitable for enrollment by the study physician.
结局指标
主要结局
The occurrence of chronic kidney diseases in non-CKD participants
时间窗: up to 5 years
The occurrence of chronic kidney disease is defined by KDIGO (Kidney Disease: Improving Global Outcomes) in 2012.
The progression of chronic kidney diseases in CKD participants
时间窗: up to 5 years
The progression of chronic kidney disease is defined as: Patients with baseline estimated glomerular filtration rate (eGFR) ≥60 ml /min/1.73m2 had an eGFR decrease of 30% or more, and decreased to \<60 ml /min/1.73m2; Or a 50% or greater decrease in baseline eGFR \<60 ml /min/1.73m2; Or end-stage renal disease (eGFR \<15 ml /min/1.73m2, or initiation of renal replacement therapy)
次要结局
- Progression in albuminuria(up to 5 years)
- Change of estimated eGFR(up to 5 years)
- Rapid decrease of renal function(up to 5 years)
- New onset of albuminuria(up to 5 years)
- New onset of macroalbuminuria(up to 5 years)
- change of uACR(up to 5 years)
- Composite endpoints of progression of chronic kidney disease and progression of albuminuria(up to 5 years)
- Composite endpoint of progression of chronic kidney disease, progression of albuminuria, and all-cause death.(up to 5 years)
研究者
XueQing Yu
Clinical Professor
Guangdong Provincial People's Hospital