Chronic Kidney DieaseNCT07494526
Chronic Kidney Disease and Metabolic Disorders in the Elderly
An observational study of Chronic Kidney Diease and Diabetes Mellitus, run by Chinese PLA General Hospital at 2 sites in China.
Trial summary
The goal of this observational study is to investigate the impact of metabolic comorbidities on outcomes in elderly Chinese adults, through two parallel sub-cohorts: one comprising elderly individuals without chronic kidney disease (CKD) at baseline, and one comprising elderly patients with established CKD. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diease, Diabetes Mellitus, Hypertension
- How many people
- 100,000 participants
- Where
- 2 sitesChina
- Study dates
- Apr 2026to 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Participants will be recruited from multiple clinical and community-based settings across China, through a network of tertiary hospitals and affiliated community health centers. The study population consists of elderly adults aged 60 years and older, divided into two sub-cohorts: Sub-cohort 1: Elderly individuals without CKD at baseline, recruited from community health centers and outpatient clinics. Sub-cohort 2: Elderly patients with established CKD, recruited from participating tertiary hospitals. Participants are drawn from geographically diverse regions of China, contributing to a nationally representative sample of the elderly population with and without chronic kidney disease.
Who may be able to join
- Baseline age ≥ 65 years.
- Availability of baseline data on serum creatinine and at least one urinary protein measurement.
- Urinary protein measurements include: UACR, UPCR, 24-hour urine protein quantification, and urine protein dipstick test.
- Baseline date requirement: Between January 1, 2010, and December 31, 2025.
- Follow-up requirement meeting at least one of the following: At least one serum creatinine measurement with an interval of ≥ 6 months after baseline. Occurrence of a primary endpoint event (new-onset CKD).
- Baseline age ≥ 65 years.
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- Meeting the diagnostic criteria for CKD: Glomerular filtration rate (eGFR) < 60 ml/(min·1.73m²) or urine protein (UACR ≥ 30 mg/g); or based on ICD-10 codes.
- Baseline date requirement: Between January 1, 2010, and December 31, 2025.
- Follow-up requirement meeting at least one of the following:
- Occurrence of a primary endpoint event (mortality, ESRD); At least one serum creatinine measurement with an interval of ≥ 6 months after baseline.
Who cannot join
- Presence of CKD at baseline, defined as: Glomerular filtration rate (eGFR) < 60 ml/(min·1.73m²) or positive urine protein; or the presence of an ICD-10 diagnostic code for CKD in medical records.
- For Sub-cohort 2 (CKD Patients), the inclusion and exclusion criteria are as follows:
- End-stage renal disease (ESRD) at baseline (eGFR < 15 ml/(min·1.73m²), or prior receipt of kidney transplant or dialysis), based on ICD codes).
- Diagnosis of acute kidney injury (AKI) within the preceding 3 months.
- New York Heart Association (NYHA) Class III or IV heart failure or occurrence of acute myocardial infarction within the preceding 6 months.
- Child-Pugh Class B or C liver cirrhosis.
- Malignant neoplasm.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
chinese PLA general hospital
Beijing, Beijing Municipality, 100853
Shuang Liang, PhD, 86+15110246423, liangshuang301@163.com
Yisha Li, PhD, 86+18911772124, xiaoyixueda@qq.com
About this study
Official title: Research on the Prevention, Control, and Intelligent Management Decision-Making for Comorbidities of Chronic Kidney Disease and Metabolic Disorders in the Elderly
The goal of this observational study is to investigate the impact of metabolic comorbidities on outcomes in elderly Chinese adults, through two parallel sub-cohorts: one comprising elderly individuals without chronic kidney disease (CKD) at baseline, and one comprising elderly patients with established CKD.
The main questions it aims to answer are:
Read more
Do metabolic diseases (diabetes, hypertension, hyperlipidemia, hyperuricemia, calcium-phosphorus disorders) increase the risk of incident CKD, major adverse cardiovascular events (MACE), and all-cause mortality in elderly individuals without CKD at baseline? What are the optimal diagnostic thresholds and criteria for CKD in the elderly population? How do metabolic comorbidities affect long-term outcomes - including all-cause mortality, end-stage renal disease (ESRD), and cardiovascular events - in elderly patients with established CKD? What is the comorbidity profile and disease burden of elderly CKD patients in China?
Participants in both sub-cohorts will:
Undergo baseline assessments including laboratory tests and clinical evaluations.
Provide longitudinal follow-up data through scheduled clinic visits and medical record linkage.
Contribute to a large-scale cohort of 100,000 elderly participants across multiple centers in China.
Read the detailed description
Background and Rationale Chronic kidney disease (CKD) complicated by metabolic disorders - including diabetes mellitus, hypertension, hyperlipidemia, hyperuricemia, and calcium-phosphorus disturbances - poses a significant public health threat to the elderly population. China is experiencing accelerating demographic aging, making the burden of CKD and metabolic comorbidity in older adults an increasingly pressing clinical and policy challenge.
Current clinical practice is often characterized by a fragmented approach in which multiple coexisting conditions are managed independently, without an integrated framework that accounts for their interactions. Furthermore, there is no international consensus on the diagnostic criteria, epidemiological characteristics, or prognostic assessment of CKD in the elderly.
Study Design
This is a multicenter, prospective and retrospective observational cohort study aiming to enroll a total of 100,000 elderly participants. The study comprises two sub-cohorts with distinct eligibility criteria and complementary scientific objectives:
Sub-cohort 1 - Incident CKD in Elderly Adults without CKD at Baseline:
Elderly individuals without CKD at baseline will be enrolled and followed longitudinally. Baseline and follow-up data will be collected to evaluate the impact of metabolic diseases (diabetes, hypertension, hyperlipidemia, hyperuricemia, calcium-phosphorus disorders) on the risk of incident CKD, major adverse cardiovascular events (MACE), and all-cause mortality. This sub-cohort will also be used to establish and validate age-appropriate diagnostic thresholds and criteria for CKD in the elderly Chinese population.
Sub-cohort 2 - Elderly CKD Patients with Metabolic Comorbidities:
Elderly patients with established CKD (stages 1-4, excluding stage 5 or those already on renal replacement therapy) will be enrolled. Baseline and longitudinal follow-up data will be used to characterize the comorbidity profile of elderly CKD patients in China, and to evaluate the effects of metabolic comorbidities on long-term outcomes, including all-cause mortality, progression to end-stage renal disease (ESRD), and cardiovascular events.
The objectives of this study are:
To describe the epidemiological characteristics and risk factor profiles of CKD-metabolic comorbidity in elderly adults in China.
To establish and validate age-appropriate diagnostic criteria and thresholds for CKD in the elderly.
To evaluate the prognostic impact of metabolic comorbidities on CKD-related outcomes.
To develop clinical decision-support tools applicable to community and home-based settings.
To provide evidence to inform the development and updating of relevant clinical guidelines.
- Keywords
- chronic kidney disease, elderly, metabolic disorders
- Medical subject headings
- Diabetes Mellitus, Hypertension, Hyperlipidemias, Hyperuricemia, Renal Insufficiency, Chronic, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sub-cohort 1 - Elderly Adults without chronic kidney disease (CKD) at Baseline | Not described | |
| Sub-cohort 2 - Elderly Patients with chronic kidney disease (CKD) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
incident CKD
For Sub-cohort 1 in Elderly Adults without CKD at Baseline, the primary outcome is incident CKD, which is defined as glomerular filtration rate (eGFR) < 60 ml/(min·1.73m²) or positive urine protein; or the presence of a clear ICD-10 diagnostic code for CKD in medical records.
Measured: through study completion, an average of 1 year
All-cause mortality
Measured: From date of enrollment until death from any cause, assessed up to 5 years
Progression to ESRD.
Measured: From date of enrollment until progression to ESRD or death from any cause, whichever came first, assessed 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 posted27 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DieaseStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Retrospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, Beijing Chao Yang Hospital, The First Affiliated Hospital of Dalian Medical University, Beijing Luhe Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Shandong Provincial Hospital, Second Xiangya Hospital of Central South University, Tianjin Medical University
- Responsible party
- Principal investigator, Yuanjun Yang, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494526
- Sponsor's protocol ID
- 2024YFC3607400
- Other IDs
- 2024YFC3607400
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data sharing is not planned at this time, due to Chinese regulations on personal information protection and human genetic resources management. Aggregated and de-identified data may be made available upon reasonable request, subject to regulatory approval.
Publications
Liu P, Sawhney S, Heide-Jorgensen U, Quinn RR, Jensen SK, Mclean A, Christiansen CF, Gerds TA, Ravani P. Predicting the risks of kidney failure and death in adults with moderate to severe chronic kidney disease: multinational, longitudinal, population based, cohort study. BMJ. 2024 Apr 15;385:e078063. doi: 10.1136/bmj-2023-078063.
PubMed 38621801
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Prevention, Control, and Intelligent Management Decision-Making for Comorbidities of Chronic Kidney Disease and Metabolic Disorders in the Elderly
- ClinicalTrials.gov ID
- NCT07494526
- Acronym / sponsor ID
- 2024YFC3607400
- Keywords
- chronic kidney disease, elderly, metabolic disorders
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Fudan University, Beijing Chao Yang Hospital, The First Affiliated Hospital of Dalian Medical University, Beijing Luhe Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Shandong Provincial Hospital, Second Xiangya Hospital of Central South University, Tianjin Medical University
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Mar 2026 (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.
The goal of this observational study is to investigate the impact of metabolic comorbidities on outcomes in elderly Chinese adults, through two parallel sub-cohorts: one comprising elderly individuals without chronic kidney disease (CKD) at baseline, and one comprising elderly patients with established CKD.
The main questions it aims to answer are:
Do metabolic diseases (diabetes, hypertension, hyperlipidemia, hyperuricemia, calcium-phosphorus disorders) increase the risk of incident CKD, major adverse cardiovascular events (MACE), and all-cause mortality in elderly individuals without CKD at baseline? What are the optimal diagnostic thresholds and criteria for CKD in the elderly population? How do metabolic comorbidities affect long-term outcomes - including all-cause mortality, end-stage renal disease (ESRD), and cardiovascular events - in elderly patients with established CKD? What is the comorbidity profile and disease burden of elderly CKD patients in China?
Participants in both sub-cohorts will:
Undergo baseline assessments including laboratory tests and clinical evaluations.
Provide longitudinal follow-up data through scheduled clinic visits and medical record linkage.
Contribute to a large-scale cohort of 100,000 elderly participants across multiple centers in China.
Detailed description
Background and Rationale Chronic kidney disease (CKD) complicated by metabolic disorders - including diabetes mellitus, hypertension, hyperlipidemia, hyperuricemia, and calcium-phosphorus disturbances - poses a significant public health threat to the elderly population. China is experiencing accelerating demographic aging, making the burden of CKD and metabolic comorbidity in older adults an increasingly pressing clinical and policy challenge.
Current clinical practice is often characterized by a fragmented approach in which multiple coexisting conditions are managed independently, without an integrated framework that accounts for their interactions. Furthermore, there is no international consensus on the diagnostic criteria, epidemiological characteristics, or prognostic assessment of CKD in the elderly.
Study Design
This is a multicenter, prospective and retrospective observational cohort study aiming to enroll a total of 100,000 elderly participants. The study comprises two sub-cohorts with distinct eligibility criteria and complementary scientific objectives:
Sub-cohort 1 - Incident CKD in Elderly Adults without CKD at Baseline:
Elderly individuals without CKD at baseline will be enrolled and followed longitudinally. Baseline and follow-up data will be collected to evaluate the impact of metabolic diseases (diabetes, hypertension, hyperlipidemia, hyperuricemia, calcium-phosphorus disorders) on the risk of incident CKD, major adverse cardiovascular events (MACE), and all-cause mortality. This sub-cohort will also be used to establish and validate age-appropriate diagnostic thresholds and criteria for CKD in the elderly Chinese population.
Sub-cohort 2 - Elderly CKD Patients with Metabolic Comorbidities:
Elderly patients with established CKD (stages 1-4, excluding stage 5 or those already on renal replacement therapy) will be enrolled. Baseline and longitudinal follow-up data will be used to characterize the comorbidity profile of elderly CKD patients in China, and to evaluate the effects of metabolic comorbidities on long-term outcomes, including all-cause mortality, progression to end-stage renal disease (ESRD), and cardiovascular events.
The objectives of this study are:
To describe the epidemiological characteristics and risk factor profiles of CKD-metabolic comorbidity in elderly adults in China.
To establish and validate age-appropriate diagnostic criteria and thresholds for CKD in the elderly.
To evaluate the prognostic impact of metabolic comorbidities on CKD-related outcomes.
To develop clinical decision-support tools applicable to community and home-based settings.
To provide evidence to inform the development and updating of relevant clinical guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sub-cohort 1 - Elderly Adults without chronic kidney disease (CKD) at Baseline | – | – |
| Sub-cohort 2 - Elderly Patients with chronic kidney disease (CKD) | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Participants will be recruited from multiple clinical and community-based settings across China, through a network of tertiary hospitals and affiliated community health centers. The study population consists of elderly adults aged 60 years and older, divided into two sub-cohorts: Sub-cohort 1: Elderly individuals without CKD at baseline, recruited from community health centers and outpatient clinics. Sub-cohort 2: Elderly patients with established CKD, recruited from participating tertiary hospitals. Participants are drawn from geographically diverse regions of China, contributing to a nationally representative sample of the elderly population with and without chronic kidney disease.
Key inclusion criteria (10 listed)
- Baseline age ≥ 65 years.
- Availability of baseline data on serum creatinine and at least one urinary protein measurement.
- Urinary protein measurements include: UACR, UPCR, 24-hour urine protein quantification, and urine protein dipstick test.
- Baseline date requirement: Between January 1, 2010, and December 31, 2025.
- Follow-up requirement meeting at least one of the following: At least one serum creatinine measurement with an interval of ≥ 6 months after baseline. Occurrence of a primary endpoint event (new-onset CKD).
Key exclusion criteria (7 listed)
- Presence of CKD at baseline, defined as: Glomerular filtration rate (eGFR) < 60 ml/(min·1.73m²) or positive urine protein; or the presence of an ICD-10 diagnostic code for CKD in medical records.
- End-stage renal disease (ESRD) at baseline (eGFR < 15 ml/(min·1.73m²), or prior receipt of kidney transplant or dialysis), based on ICD codes).
- Diagnosis of acute kidney injury (AKI) within the preceding 3 months.
- New York Heart Association (NYHA) Class III or IV heart failure or occurrence of acute myocardial infarction within the preceding 6 months.
- Child-Pugh Class B or C liver cirrhosis.
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
incident CKD
Time frame: through study completion, an average of 1 year
For Sub-cohort 1 in Elderly Adults without CKD at Baseline, the primary outcome is incident CKD, which is defined as glomerular filtration rate (eGFR) < 60 ml/(min·1.73m²) or positive urine protein; or the presence of a clear ICD-10 diagnostic code for CKD in medical records.
All-cause mortality
Time frame: From date of enrollment until death from any cause, assessed up to 5 years
Progression to ESRD.
Time frame: From date of enrollment until progression to ESRD or death from any cause, whichever came first, assessed 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 27 Mar 2026.
- Background: PubMed 38621801Liu P, Sawhney S, Heide-Jorgensen U, Quinn RR, Jensen SK, Mclean A, Christiansen CF, Gerds TA, Ravani P. Predicting the risks of kidney failure and death in adults with moderate to severe chronic kidney disease: multinational, longitudinal, population based, cohort study. BMJ. 2024 Apr 15;385:e078063. doi: 10.1136/bmj-2023-078063.
- Individual participant dataSharing planned: No. Individual participant data sharing is not planned at this time, due to Chinese regulations on personal information protection and human genetic resources management. Aggregated and de-identified data may be made available upon reasonable request, subject to regulatory approval.
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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.
2 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 Diease and Diabetes Mellitus, run by Chinese PLA General Hospital at 2 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 10 inclusion and 7 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: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Shuang Liang (86+15110246423, liangshuang301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incident CKD (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07494526, which also lists 1 linked publication.
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 27 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.