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

NCT05188885 | Recruiting DMC

• 1 other identifier: GDPH-CKD-MIP-01
• Study Type: observational
• Target: 90,000
• Locations: 1 country
• Sites: 8

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.

Conditions

Chronic Kidney Disease

Keywords

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Progression in albuminuria

  up to 5 years

• New onset of albuminuria

  up to 5 years

• New onset of macroalbuminuria

  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

Other Outcomes (12)

• The occurrence and development of complications of chronic renal disease

  up to 5 years

• Rate of Participants with cardiovascular events.

  up to 5 years

• Rate of Participants with cerebrovascular events.

  up to 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Enrolled based on both hospitals and communities.

You may qualify if:

• 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.

You may not qualify if:

• 。Patients identified to be unsuitable for enrollment by the study physician.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (8)

The Second People's Hospital of Nanhai District in Foshan City

Foshan, Guangdong, China

NOT YET RECRUITING

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

NOT YET RECRUITING

Wuhua County People's Hospital

Meizhou, Guangdong, China

NOT YET RECRUITING

Fogang County People's Hospital

Qingyuan, Guangdong, China

NOT YET RECRUITING

People's Hospital of Yingde

Qingyuan, Guangdong, China

NOT YET RECRUITING

Zhuhai Golden Bay Central Hospital

Zhuhai, Guangdong, China

NOT YET RECRUITING

Ganzhou Municipal Hospital

Ganzhou, Jiangxi, China

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, white cells, urine, urine sediment

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xueqing Yu, MD

  Guangdong Provincial People's Hospital

  STUDY CHAIR

• Zhiming Ye, MD

  Guangdong Provincial People's Hospital

  STUDY DIRECTOR

• Feng Wen, MD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Ting Lin, MD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xueqing Yu, MD

CONTACT

+86-20-83827812; yuxueqing@gdph.org.cn

Feng Wen, MD

CONTACT

+86-20-83827812; dreammore@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 12, 2022
• Study Start: December 27, 2021
• Primary Completion (Estimated): December 27, 2026
• Study Completion (Estimated): December 27, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (8)