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

January 13, 2026 updated by: XueQing Yu, Guangdong Provincial People's Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The occurrence of chronic kidney diseases in non-CKD participants
Time Frame: up to 5 years
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
Time Frame: 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)
up to 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression in albuminuria
Time Frame: 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.
up to 5 years
New onset of albuminuria
Time Frame: up to 5 years
Onset of albuminuria: Patients with baseline uACR <30 mg/g increased to ≥30 mg/g.
up to 5 years
New onset of macroalbuminuria
Time Frame: up to 5 years
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
Time Frame: 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.
Time Frame: up to 5 years
Composite endpoint of progression of chronic kidney disease, progression of albuminuria, and all-cause death.
up to 5 years
Change of estimated eGFR
Time Frame: up to 5 years
Change rate per year.
up to 5 years
change of uACR
Time Frame: up to 5 years
Change rate per year.
up to 5 years
Rapid decrease of renal function
Time Frame: up to 5 years
The annual decrease rate of eGFR was > 5mL/min/1.73m2.
up to 5 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The occurrence and development of complications of chronic renal disease
Time Frame: up to 5 years
Renal anemia, renal hypertension, mineral bone metabolism disorders, etc.
up to 5 years
Rate of Participants with cardiovascular events.
Time Frame: up to 5 years
Rate of Participants with cardiovascular events.
up to 5 years
Rate of Participants with cerebrovascular events.
Time Frame: up to 5 years
Rate of Participants with cerebrovascular events.
up to 5 years
All causes mortality
Time Frame: up to 5 years
All causes mortality.
up to 5 years
Rate of Participants with hospitalization.
Time Frame: up to 5 years
Rate of Participants with hospitalization.
up to 5 years
Changes in cognitive function score.
Time Frame: up to 5 years
Changes in cognitive function score by questionnaire.
up to 5 years
Rate of Participants with new-onset diabetes
Time Frame: up to 5 years
Rate of Participants with new-onset diabetes.
up to 5 years
Rate of Participants with severe infection
Time Frame: up to 5 years
Rate of Participants with infections that need intravenous injections or hospitalization.
up to 5 years
Rate of Participants with bone fracture
Time Frame: up to 5 years
Rate of Participants with bone fracture.
up to 5 years
Rate of Participants with tumor
Time Frame: up to 5 years
Rate of Participants with tumors.
up to 5 years
Rate of Participants with malnutrition
Time Frame: up to 5 years
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
Time Frame: up to 5 years
Rate of Participants with pregnancy and birth
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangdong Provincial People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 27, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 27, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 27, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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