Chronic Kidney DiseaseNCT05188885
A Real World, Multi-centric, Observational Registry Study of Chronic Kidney Diseases
An observational study of Chronic Kidney Disease, run by Guangdong Provincial People's Hospital at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 90,000 participants
- Where
- 8 sitesChina
- Study dates
- 27 Dec 2021to 27 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Enrolled based on both hospitals and communities.
Who may be able to join
- 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.
Who cannot join
- 。Patients identified to be unsuitable for enrollment by the study physician.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 8 recruiting
- Not yet recruiting
The Second People's Hospital of Nanhai District in Foshan City
Foshan, Guangdong
Xia jiang
xia jiang
- Not yet recruiting
Ganzhou Municipal Hospital
Ganzhou, Jiangxi
Ruifang Hua
Ruifang Hua
- Recruiting
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong
Xueqing Yu
Xueqing Yu
- Not yet recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Wei Chen
Wei Chen
- Not yet recruiting
Wuhua County People's Hospital
Meizhou, Guangdong
Yusheng Zhang
Yusheng Zhang
- Not yet recruiting
Fogang County People's Hospital
Qingyuan, Guangdong
Youhe Li
Youhe Li
- Not yet recruiting
People's Hospital of Yingde
Qingyuan, Guangdong
Guangbiao Pan
Guangbiao Pan
- Not yet recruiting
Zhuhai Golden Bay Central Hospital
Zhuhai, Guangdong
Juan Pang
Juan Pang
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: up to 5 years
Secondary outcomes (8)
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.
Measured: up to 5 years
New onset of albuminuria
Onset of albuminuria: Patients with baseline uACR <30 mg/g increased to ≥30 mg/g.
Measured: up to 5 years
New onset of macroalbuminuria
Onset of macroalbuminuria: Patients with baseline uACR <300 mg/g increased to ≥300 mg/g.
Measured: 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.
Measured: 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.
Measured: up to 5 years
Change of estimated eGFR
Change rate per year.
Measured: up to 5 years
change of uACR
Change rate per year.
Measured: up to 5 years
Rapid decrease of renal function
The annual decrease rate of eGFR was > 5mL/min/1.73m2.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start27 Dec 2021
- Primary completion27 Dec 2026 (estimated)
- Study completion27 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XueQing Yu, Guangdong Provincial People's Hospital
- Investigators
- Xueqing Yu, MD, Study chair, Guangdong Provincial People's HospitalZhiming Ye, MD, Study director, Guangdong Provincial People's HospitalFeng Wen, MD, Principal investigator, Guangdong Provincial People's HospitalTing Lin, MD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188885
- Sponsor's protocol ID
- GDPH-CKD-MIP-01
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2021
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World, Multi-centric, Observational Registry Study of Chronic Kidney Diseases
- ClinicalTrials.gov ID
- NCT05188885
- Acronym / sponsor ID
- GDPH-CKD-MIP-01
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90,000 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 27 Dec 2021 (actual)
- Primary completion
- 27 Dec 2026 (estimated)
- Study completion
- 27 Dec 2028 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Enrolled based on both hospitals and communities.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 。Patients identified to be unsuitable for enrollment by the study physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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)
8 secondary outcomes
Progression in albuminuria
Time frame: up to 5 years
New onset of albuminuria
Time frame: up to 5 years
New onset of macroalbuminuria
Time frame: up to 5 years
Composite endpoints of progression of chronic kidney disease and progression of albuminuria
Time frame: 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
Change of estimated eGFR
Time frame: up to 5 years
change of uACR
Time frame: up to 5 years
Rapid decrease of renal function
Time frame: up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xueqing Yu, MD study chair
Guangdong Provincial People's Hospital
Zhiming Ye, MD study director
Guangdong Provincial People's Hospital
Feng Wen, MD principal investigator
Guangdong Provincial People's Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Guangdong Provincial People's Hospital at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xueqing Yu, MD (+86-20-83827812, yuxueqing@gdph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of chronic kidney diseases in non-CKD participants (time frame: up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.