Clinical trial NCT05188885: A Real World, Multi-centric, Observational Registry Study of Chronic Kidney Diseases
Official title: A Real World, Multi-centric, Observational Registry Study of Chronic Kidney Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 90000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enrolled based on both hospitals and communities.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The occurrence of chronic kidney diseases in non-CKD participants
timeFrame: up to 5 years
measure: The progression of chronic kidney diseases in CKD participants
timeFrame: up to 5 years
Secondary outcomes:
measure: Progression in albuminuria
timeFrame: up to 5 years
measure: New onset of albuminuria
timeFrame: up to 5 years
measure: New onset of macroalbuminuria
timeFrame: up to 5 years
measure: Composite endpoints of progression of chronic kidney disease and progression of albuminuria
timeFrame: up to 5 years
measure: Composite endpoint of progression of chronic kidney disease, progression of albuminuria, and all-cause death.
timeFrame: up to 5 years
measure: Change of estimated eGFR
timeFrame: up to 5 years
measure: change of uACR
timeFrame: up to 5 years
measure: Rapid decrease of renal function
timeFrame: up to 5 years
Other outcomes:
measure: The occurrence and development of complications of chronic renal disease
timeFrame: up to 5 years
measure: Rate of Participants with cardiovascular events.
timeFrame: up to 5 years
measure: Rate of Participants with cerebrovascular events.
timeFrame: up to 5 years
measure: All causes mortality
timeFrame: up to 5 years
measure: Rate of Participants with hospitalization.
timeFrame: up to 5 years
measure: Changes in cognitive function score.
timeFrame: up to 5 years
measure: Rate of Participants with new-onset diabetes
timeFrame: up to 5 years
measure: Rate of Participants with severe infection
timeFrame: up to 5 years
measure: Rate of Participants with bone fracture
timeFrame: up to 5 years
measure: Rate of Participants with tumor
timeFrame: up to 5 years
measure: Rate of Participants with malnutrition
timeFrame: up to 5 years
measure: Rate of Participants with pregnancy
timeFrame: up to 5 years
Locations:
city: Foshan
country: China
facility: The Second People's Hospital of Nanhai District in Foshan City
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial Peoples Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Meizhou
country: China
facility: Wuhua County People's Hospital
state: Guangdong
city: Qingyuan
country: China
facility: Fogang County People's Hospital
state: Guangdong
city: Qingyuan
country: China
facility: People's Hospital of Yingde
state: Guangdong
city: Zhuhai
country: China
facility: Zhuhai Golden Bay Central Hospital
state: Guangdong
city: Ganzhou
country: China
facility: Ganzhou Municipal Hospital
state: Jiangxi
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Xueqing Yu, MD
role: STUDY_CHAIR
affiliation: Guangdong Provincial People's Hospital
name: Zhiming Ye, MD
role: STUDY_DIRECTOR
affiliation: Guangdong Provincial People's Hospital
name: Feng Wen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangdong Provincial People's Hospital
name: Ting Lin, MD
role: PRINCIPAL_INVESTIGATOR
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