Kidney Function DeclineNCT07765134
Comprehensive Kidney Function Assessment and Early Warning in Older Adults
An observational study of Kidney Function Decline and Chronic Kidney Disease, run by Huashan Hospital at 1 site in China.
Trial summary
This completed observational cohort study evaluates a comprehensive set of clinical and molecular markers of kidney function in two established cohorts of Chinese adults aged 60 years or older. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Function Decline, Chronic Kidney Disease, Kidney Failure
- How many people
- 5,588 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2021to 6 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population comprises adults aged 60 years or older selected from two established Chinese cohorts. The Rugao Longevity and Ageing Study primarily includes community-dwelling older adults, whereas the Shanghai Older-Adult Cohort includes older adults with comorbid conditions. Eligible participants had a baseline estimated glomerular filtration rate greater than 60 mL/min/1.73 m² and the clinical, follow-up, and biospecimen data required for the relevant analyses.
Who may be able to join
- Enrollment in the Rugao Longevity and Ageing Study or the Shanghai Older-Adult Cohort.
- Age 60 years or older, of either sex, with a baseline estimated glomerular filtration rate greater than 60 mL/min/1.73 m².
- Availability of the baseline data required for the study, including blood pressure, body weight, body mass index, smoking and alcohol use, surgical history, family history, complete blood count, liver function, electrolytes, kidney function, serum cystatin C, blood glucose, urinalysis, and urinary albumin-to-creatinine ratio.
- Availability of follow-up information sufficient to ascertain the prespecified clinical outcomes.
- Clinically stable condition and adequate ability to understand and communicate at enrollment in the parent cohort.
- Written informed consent for participation and the permitted research use of clinical data and stored biospecimens.
Who cannot join
- Missing essential baseline or follow-up data required for the relevant analysis.
- Unavailability of stored blood or urine specimens required for the planned biomarker analysis.
- Missing information on lifestyle, health-related behaviors, or social support required for the relevant analysis.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
Official title: Comprehensive Clinical Assessment and Management of Kidney Function Decline in Older Adults and Development of an Early Warning System
This completed observational cohort study evaluates a comprehensive set of clinical and molecular markers of kidney function in two established cohorts of Chinese adults aged 60 years or older. The study assesses markers reflecting glomerular filtration, kidney tubular transport, and kidney endocrine function and evaluates their associations with kidney failure, cardiovascular and cerebrovascular events, and all-cause mortality. It also compares approaches to estimating glomerular filtration rate and develops and internally validates an early-warning model for kidney function decline. Existing baseline and follow-up data and stored serum and urine specimens are used. No intervention or additional study-specific clinical procedure is administered.
Read the detailed description
The study includes 5,588 participants, comprising 1,788 participants from the Rugao Longevity and Ageing Study and 3,800 participants from the Shanghai Older-Adult Cohort. The study uses existing demographic, lifestyle, clinical, and laboratory data, longitudinal follow-up information, and measurements obtained from stored serum and urine specimens. No intervention is assigned, and no additional study-specific examination or biospecimen collection is performed.
Markers reflecting glomerular filtration, kidney tubular transport, and kidney endocrine function are evaluated in relation to incident kidney failure, cardiovascular and cerebrovascular events, and all-cause mortality. Approaches to estimating glomerular filtration rate and combinations of kidney function-related biomarkers are compared for prognostic assessment. Multivariable linear, logistic, and Cox proportional hazards regression models are used, as appropriate, to evaluate associations while accounting for potential confounding factors.
For prediction modeling, the analytic sample is divided in a 7:3 ratio into model-development and internal-validation sets. Statistical learning and machine-learning methods, including random forests, decision trees, support vector machines, and neural-network approaches, are evaluated. Cross-validation is used during model development and model selection. The study also supports the development of a secure, access-controlled data-sharing and analytics platform.
- Keywords
- Older Adults, Glomerular Filtration Rate, Estimated Glomerular Filtration Rate
- Medical subject headings
- Renal Insufficiency, Chronic, Renal Insufficiency
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 |
|---|---|---|
| Rugao Longevity and Ageing Study Cohort | This cohort comprises eligible older adults from the established Rugao Longevity and Ageing Study. Participants contribute existing baseline and follow-up data and, when available, stored serum and urine specimens. No intervention is assigned. Clinical and molecular markers of kidney function are evaluated in relation to subsequent kidney failure, cardiovascular and cerebrovascular events, and all-cause mortality. | |
| Shanghai Older-Adult Cohort | This cohort comprises eligible older adults with comorbid conditions from the established Shanghai Older-Adult Cohort. Participants contribute existing baseline and follow-up data and, when available, stored serum and urine specimens. No intervention is assigned. Clinical and molecular markers of kidney function are evaluated in relation to subsequent kidney failure, cardiovascular and cerebrovascular events, and all-cause mortality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident End-Stage Kidney Disease
First occurrence of end-stage kidney disease documented in cohort follow-up or clinical records.
Measured: From cohort baseline through the end of available follow-up, up to 10 years
Incident Cardiovascular or Cerebrovascular Event
First occurrence of a clinically documented cardiovascular or cerebrovascular event, including coronary heart disease, myocardial infarction, heart failure, or stroke, ascertained from cohort follow-up and medical records.
Measured: From cohort baseline through the end of available follow-up, up to 10 years
All-Cause Mortality
Death from any cause, ascertained from survival follow-up and death records.
Measured: From cohort baseline through the end of available follow-up, up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start10 Dec 2021
- Primary completion6 Sep 2022
- Study completion6 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Function DeclineStudies of the same condition, open and under way.
- 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
- 5,588 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Jing, Huashan Hospital
- Investigators
- Jing Chen, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765134
- Sponsor's protocol ID
- KY2021-877
- Other IDs
- 2020YFC2005003
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Clinical Assessment and Management of Kidney Function Decline in Older Adults and Development of an Early Warning System
- ClinicalTrials.gov ID
- NCT07765134
- Acronym / sponsor ID
- KY2021-877
- Keywords
- Older Adults, Glomerular Filtration Rate, Estimated Glomerular Filtration Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,588 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 14 Aug 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.
This completed observational cohort study evaluates a comprehensive set of clinical and molecular markers of kidney function in two established cohorts of Chinese adults aged 60 years or older. The study assesses markers reflecting glomerular filtration, kidney tubular transport, and kidney endocrine function and evaluates their associations with kidney failure, cardiovascular and cerebrovascular events, and all-cause mortality. It also compares approaches to estimating glomerular filtration rate and develops and internally validates an early-warning model for kidney function decline. Existing baseline and follow-up data and stored serum and urine specimens are used. No intervention or additional study-specific clinical procedure is administered.
Detailed description
The study includes 5,588 participants, comprising 1,788 participants from the Rugao Longevity and Ageing Study and 3,800 participants from the Shanghai Older-Adult Cohort. The study uses existing demographic, lifestyle, clinical, and laboratory data, longitudinal follow-up information, and measurements obtained from stored serum and urine specimens. No intervention is assigned, and no additional study-specific examination or biospecimen collection is performed.
Markers reflecting glomerular filtration, kidney tubular transport, and kidney endocrine function are evaluated in relation to incident kidney failure, cardiovascular and cerebrovascular events, and all-cause mortality. Approaches to estimating glomerular filtration rate and combinations of kidney function-related biomarkers are compared for prognostic assessment. Multivariable linear, logistic, and Cox proportional hazards regression models are used, as appropriate, to evaluate associations while accounting for potential confounding factors.
For prediction modeling, the analytic sample is divided in a 7:3 ratio into model-development and internal-validation sets. Statistical learning and machine-learning methods, including random forests, decision trees, support vector machines, and neural-network approaches, are evaluated. Cross-validation is used during model development and model selection. The study also supports the development of a secure, access-controlled data-sharing and analytics platform.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rugao Longevity and Ageing Study Cohort | – | –This cohort comprises eligible older adults from the established Rugao Longevity and Ageing Study. Participants contribute existing baseline and follow-up data and, when available, stored serum and urine specimens. No intervention is assigned. Clinical and molecular markers of kidney function are evaluated in relation to subsequent kidney failure, cardiovascular and cerebrovascular events, and all-cause mortality. |
| Shanghai Older-Adult Cohort | – | –This cohort comprises eligible older adults with comorbid conditions from the established Shanghai Older-Adult Cohort. Participants contribute existing baseline and follow-up data and, when available, stored serum and urine specimens. No intervention is assigned. Clinical and molecular markers of kidney function are evaluated in relation to subsequent kidney failure, cardiovascular and cerebrovascular events, and all-cause mortality. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises adults aged 60 years or older selected from two established Chinese cohorts. The Rugao Longevity and Ageing Study primarily includes community-dwelling older adults, whereas the Shanghai Older-Adult Cohort includes older adults with comorbid conditions. Eligible participants had a baseline estimated glomerular filtration rate greater than 60 mL/min/1.73 m² and the clinical, follow-up, and biospecimen data required for the relevant analyses.
Key inclusion criteria (6 listed)
- Enrollment in the Rugao Longevity and Ageing Study or the Shanghai Older-Adult Cohort.
- Age 60 years or older, of either sex, with a baseline estimated glomerular filtration rate greater than 60 mL/min/1.73 m².
- Availability of the baseline data required for the study, including blood pressure, body weight, body mass index, smoking and alcohol use, surgical history, family history, complete blood count, liver function, electrolytes, kidney function, serum cystatin C, blood glucose, urinalysis, and urinary albumin-to-creatinine ratio.
- Availability of follow-up information sufficient to ascertain the prespecified clinical outcomes.
- Clinically stable condition and adequate ability to understand and communicate at enrollment in the parent cohort.
Key exclusion criteria (3 listed)
- Missing essential baseline or follow-up data required for the relevant analysis.
- Unavailability of stored blood or urine specimens required for the planned biomarker analysis.
- Missing information on lifestyle, health-related behaviors, or social support required for the relevant analysis.
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 End-Stage Kidney Disease
Time frame: From cohort baseline through the end of available follow-up, up to 10 years
First occurrence of end-stage kidney disease documented in cohort follow-up or clinical records.
Incident Cardiovascular or Cerebrovascular Event
Time frame: From cohort baseline through the end of available follow-up, up to 10 years
First occurrence of a clinically documented cardiovascular or cerebrovascular event, including coronary heart disease, myocardial infarction, heart failure, or stroke, ascertained from cohort follow-up and medical records.
All-Cause Mortality
Time frame: From cohort baseline through the end of available follow-up, up to 10 years
Death from any cause, ascertained from survival follow-up and death records.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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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. This study is not recruiting at the moment.
Jing Chen principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Function Decline and Chronic Kidney Disease, run by Huashan Hospital at 1 site 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident End-Stage Kidney Disease (time frame: From cohort baseline through the end of available follow-up, up to 10 years). 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?
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 14 Aug 2026.