A Real World, Multi-centric, Observational Registry Study of Chronic Kidney Diseases

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Real World, Multi-centric, Observational Registry Study of Chronic Kidney Diseases

Conditions
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Chronic Kidney Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 。Patients identified to be unsuitable for enrollment by the study physician.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of chronic kidney diseases in non-CKD participants | The occurrence of chronic kidney disease is defined by KDIGO (Kidney Disease: Improving Global Outcomes) in 2012. | up to 5 years | 
| The progression of chronic kidney diseases in CKD participants | 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) | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression in albuminuria | Progression in albuminuria: Patients with baseline urinary albumin to creatinine Ratio (uACR) <30 mg/g had uACR doubled and increased to ≥30 mg/g; or patients with baseline uACR <300 mg/g had a doubling of uACR and an increase to ≥300 mg/g. | up to 5 years | 
| New onset of albuminuria | Onset of albuminuria: Patients with baseline uACR <30 mg/g increased to ≥30 mg/g. | up to 5 years | 
| New onset of macroalbuminuria | Onset of macroalbuminuria: Patients with baseline uACR <300 mg/g increased to ≥300 mg/g. | up to 5 years | 
| Composite endpoints of progression of chronic kidney disease and progression of albuminuria | 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. | Composite endpoint of progression of chronic kidney disease, progression of albuminuria, and all-cause death. | up to 5 years | 
| Change of estimated eGFR | Change rate per year. | up to 5 years | 
| change of uACR | Change rate per year. | up to 5 years | 
| Rapid decrease of renal function | The annual decrease rate of eGFR was > 5mL/min/1.73m2. | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Kidney Disease