Comprehensive Kidney Function Assessment and Early Warning in Older Adults

NCT07765134 | Completed

• 2 other identifiers: KY2021-8772020YFC2005003
• Study Type: observational
• Target: 5,588
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Function Decline; Chronic Kidney Disease; Kidney Failure

Keywords

Older Adults; Glomerular Filtration Rate; Estimated Glomerular Filtration Rate

Outcome Measures

Primary Outcomes (3)

• Incident End-Stage Kidney Disease

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

  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.

  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.

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

Study Arms (2)

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jing Chen

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start: December 10, 2021
• Primary Completion: September 6, 2022
• Study Completion: September 6, 2022
• Last Updated: August 14, 2026

Record last verified: 2026-08

Locations

CN (1)