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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease

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.

• Study Type: Observational
• Enrollment (Estimated): 90000

Contacts and Locations

• Study Contact: Name: Xueqing Yu, MD; Phone Number: +86-20-83827812; Email: yuxueqing@gdph.org.cn
• Study Contact Backup: Name: Feng Wen, MD; Phone Number: +86-20-83827812; Email: dreammore@163.com

Study Locations

• China
  • Guangdong
    • Foshan, Guangdong, China
      • Not yet recruiting
      • The Second People's Hospital of Nanhai District in Foshan City
      • Contact: Xia jiang
      • Principal Investigator: xia jiang
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • The First Affiliated Hospital of Sun Yat-sen University
      • Contact: Wei Chen
      • Principal Investigator: Wei Chen
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangdong Provincial Peoples Hospital
      • Contact: Xueqing Yu
      • Principal Investigator: Xueqing Yu
    • Meizhou, Guangdong, China
      • Not yet recruiting
      • Wuhua County People's Hospital
      • Contact: Yusheng Zhang
      • Principal Investigator: Yusheng Zhang
    • Qingyuan, Guangdong, China
      • Not yet recruiting
      • Fogang County People's Hospital
      • Contact: Youhe Li
      • Principal Investigator: Youhe Li
    • Qingyuan, Guangdong, China
      • Not yet recruiting
      • People's Hospital of Yingde
      • Contact: Guangbiao Pan
      • Principal Investigator: Guangbiao Pan
    • Zhuhai, Guangdong, China
      • Not yet recruiting
      • Zhuhai Golden Bay Central Hospital
      • Contact: Juan Pang
      • Principal Investigator: Juan Pang
  • Jiangxi
    • Ganzhou, Jiangxi, China
      • Not yet recruiting
      • Ganzhou Municipal Hospital
      • Contact: Ruifang Hua
      • Principal Investigator: Ruifang Hua

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Enrolled based on both hospitals and communities.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The occurrence and development of complications of chronic renal disease	Renal anemia, renal hypertension, mineral bone metabolism disorders, etc.	up to 5 years
Rate of Participants with cardiovascular events.	Rate of Participants with cardiovascular events.	up to 5 years
Rate of Participants with cerebrovascular events.	Rate of Participants with cerebrovascular events.	up to 5 years
All causes mortality	All causes mortality.	up to 5 years
Rate of Participants with hospitalization.	Rate of Participants with hospitalization.	up to 5 years
Changes in cognitive function score.	Changes in cognitive function score by questionnaire.	up to 5 years
Rate of Participants with new-onset diabetes	Rate of Participants with new-onset diabetes.	up to 5 years
Rate of Participants with severe infection	Rate of Participants with infections that need intravenous injections or hospitalization.	up to 5 years
Rate of Participants with bone fracture	Rate of Participants with bone fracture.	up to 5 years
Rate of Participants with tumor	Rate of Participants with tumors.	up to 5 years
Rate of Participants with malnutrition	A decrease of body weight more than 15%, and/or serum albumin decreased to less than 30 g/L.	up to 5 years
Rate of Participants with pregnancy	Rate of Participants with pregnancy and birth	up to 5 years

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Investigators: Study Chair: Xueqing Yu, MD, Guangdong Provincial People's Hospital; Study Director: Zhiming Ye, MD, Guangdong Provincial People's Hospital; Principal Investigator: Feng Wen, MD, Guangdong Provincial People's Hospital; Principal Investigator: Ting Lin, MD, Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2021
• Primary Completion (Estimated): December 27, 2026
• Study Completion (Estimated): December 27, 2028

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: January 11, 2022
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: GDPH-CKD-MIP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified study data that supports the results will be shared following publication. Any sub-study analysis and publication will have to be reviewed and approved by the Trial Steering Committee, local Ethics and Regulatory requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No