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Completed

NCT Number: NCT07765134

Comprehensive Kidney Function Assessment and Early Warning in Older Adults

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

Comprehensive Clinical Assessment and Management of Kidney Function Decline in Older Adults and Development of an Early Warning System

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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