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CompletedNCT07765134Updated Aug 14, 2026

Comprehensive Kidney Function Assessment and Early Warning in Older Adults

An observational study in Kidney Function Decline, Chronic Kidney Disease and Kidney Failure, sponsored by Huashan Hospital. Completed at 1 site in China. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Huashan Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
5,588
Ages
60 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Kidney Function Decline
  • Chronic Kidney Disease
  • Kidney Failure

Keywords

  • Older Adults
  • Glomerular Filtration Rate
  • Estimated Glomerular Filtration Rate
03

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Inclusion criteria

  1. Enrollment in the Rugao Longevity and Ageing Study or the Shanghai Older-Adult Cohort.
  2. Age 60 years or older, of either sex, with a baseline estimated glomerular filtration rate greater than 60 mL/min/1.73 m².
  3. 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.
  4. Availability of follow-up information sufficient to ascertain the prespecified clinical outcomes.
  5. Clinically stable condition and adequate ability to understand and communicate at enrollment in the parent cohort.
  6. Written informed consent for participation and the permitted research use of clinical data and stored biospecimens.

Exclusion criteria

Exclusion Criteria:

  1. Missing essential baseline or follow-up data required for the relevant analysis.
  2. Unavailability of stored blood or urine specimens required for the planned biomarker analysis.
  3. Missing information on lifestyle, health-related behaviors, or social support required for the relevant analysis.
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
5,588 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. Incident End-Stage Kidney Disease

    First occurrence of end-stage kidney disease documented in cohort follow-up or clinical records.

    Time frame: From cohort baseline through the end of available follow-up, up to 10 years

  2. 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.

    Time frame: From cohort baseline through the end of available follow-up, up to 10 years

  3. All-Cause Mortality

    Death from any cause, ascertained from survival follow-up and death records.

    Time frame: From cohort baseline through the end of available follow-up, up to 10 years

06

Study locations

1 site
  • Huashan Hospital, Fudan University
    Shanghai, Shanghai Municipality 200040, China
07

Registry details

Key details

Study ID
NCT07765134
Lead sponsor
Huashan Hospital
Responsible party
Chen Jing (Professor, Huashan Hospital) — Principal investigator
First posted
Aug 14, 2026
Start date
Dec 10, 2021
Primary completion
Sep 6, 2022
Completion
Sep 6, 2022
Last update
Aug 14, 2026

Study contacts

Jing Chen
principal investigator · Huashan Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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