Rapid Kidney Function Decline in Older Adults

January 5, 2025 updated by: Chen Jing, Huashan Hospital

Identification of Rapid Kidney Function Decline in Older Adults with Different Types of Aging

This observational study investigates whether a single set of GFR and urine albumin-to-creatinine ratio (ACR) thresholds can accurately screen for rapid kidney function decline in different elderly groups.

Study Overview

Study Type

Observational

Enrollment (Actual)

1539

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

kidney disease patient

Description

Inclusion Criteria:

  1. Age greater than 70 years;
  2. GFR data measured at least twice (two years apart) and ACR data measured once (at baseline);
  3. A clear record of the cause of the previous visit; from this, people diagnosed with kidney disease were selected, and kidney disease was defined as various primary nephritis, secondary nephropathy, acute kidney injury (AKI), chronic kidney disease, kidney tumors, or a diagnosis of proteinuria alone.
  4. Signed informed consent form.

Exclusion Criteria:

  1. People with missing baseline biochemical data;
  2. Outliers in the population indicators, i.e., data deviating from the mean ± three times the standard deviation;
  3. Data with significantly abnormal baseline renal function follow-up (abnormally elevated GFR by more than 10% within 2 years or abnormal ACR value as determined by consultation with a senior nephrologist).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Rugao Longevity and Aging Study (RLAS) cohort
A total of 1,236 older adults from the Rugao Longevity and Aging Study (RLAS) were enrolled in the study, including 575 healthy aging individuals and 661 with comorbid co-morbidities (e.g., diabetes mellitus, hypertension, coronary heart disease, etc.). The objective of the study was twofold: first, to assess the predictive value of baseline glomerular filtration rate (GFR) to urinary albumin-creatinine ratio (ACR) for rapid decline in renal function (≥30% decline in GFR) within 2 years; and second, to establish early warning criteria for different types of aging populations.
Healthcare data from Huashan Hospital, Fudan University (CKD)
The present cohort comprised 303 elderly patients suffering from chronic kidney disease (CKD) from Huashan Hospital of Fudan University, including cases progressing from acute kidney injury (AKI) to CKD. The objective of the study was twofold: first, to assess the predictive ability of baseline GFR and ACR levels for rapid decline in renal function (≥30% GFR) within two years; and second, to establish appropriate early risk assessment criteria for the elderly CKD population.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A ≥30% decline in glomerular filtration rate (GFR) within 2 years, i.e. a rapid decline in renal function
Time Frame: The risk of rapid decline in kidney function in the elderly was assessed during a 2-year follow-up period
The risk of rapid decline in kidney function in the elderly was assessed during a 2-year follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jing Chen, PhD, MD, Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2011

Primary Completion (Actual)

December 25, 2022

Study Completion (Actual)

December 25, 2022

Study Registration Dates

First Submitted

January 5, 2025

First Submitted That Met QC Criteria

January 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 5, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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