Chronic Kidney Disease
Conditions
Keywords
Chronic Kidney Disease
Brief summary
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
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.
Interventions
None listed
Sponsors
Guangdong Provincial People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The occurrence of chronic kidney diseases in non-CKD participants | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New onset of macroalbuminuria | up to 5 years | Onset of macroalbuminuria: Patients with baseline uACR \<300 mg/g increased to ≥300 mg/g. |
| Composite endpoints of progression of chronic kidney disease and progression of albuminuria | up to 5 years | Composite endpoints of progression of chronic kidney disease and progression of albuminuria. |
| Composite endpoint of progression of chronic kidney disease, progression of albuminuria, and all-cause death. | up to 5 years | Composite endpoint of progression of chronic kidney disease, progression of albuminuria, and all-cause death. |
| Progression in albuminuria | up to 5 years | 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. |
| change of uACR | up to 5 years | Change rate per year. |
| Rapid decrease of renal function | up to 5 years | The annual decrease rate of eGFR was \> 5mL/min/1.73m2. |
| Change of estimated eGFR | up to 5 years | Change rate per year. |
| New onset of albuminuria | up to 5 years | Onset of albuminuria: Patients with baseline uACR \<30 mg/g increased to ≥30 mg/g. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of Participants with malnutrition | up to 5 years | A decrease of body weight more than 15%, and/or serum albumin decreased to less than 30 g/L. |
| The occurrence and development of complications of chronic renal disease | up to 5 years | Renal anemia, renal hypertension, mineral bone metabolism disorders, etc. |
| Rate of Participants with pregnancy | up to 5 years | Rate of Participants with pregnancy and birth |
| Rate of Participants with cardiovascular events. | up to 5 years | Rate of Participants with cardiovascular events. |
| Rate of Participants with cerebrovascular events. | up to 5 years | Rate of Participants with cerebrovascular events. |
| All causes mortality | up to 5 years | All causes mortality. |
| Rate of Participants with hospitalization. | up to 5 years | Rate of Participants with hospitalization. |
| Changes in cognitive function score. | up to 5 years | Changes in cognitive function score by questionnaire. |
| Rate of Participants with new-onset diabetes | up to 5 years | Rate of Participants with new-onset diabetes. |
| Rate of Participants with severe infection | up to 5 years | Rate of Participants with infections that need intravenous injections or hospitalization. |
| Rate of Participants with bone fracture | up to 5 years | Rate of Participants with bone fracture. |
| Rate of Participants with tumor | up to 5 years | Rate of Participants with tumors. |
Countries
China
Contacts
Primary ContactXueqing Yu, MD
Backup ContactFeng Wen, MD
Outcome results
None listed