- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06765811
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
Status
Completed
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
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Shanghai
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Shanghai, Shanghai, China, 200040
- Huashan Hospital, Fudan University
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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:
- Age greater than 70 years;
- GFR data measured at least twice (two years apart) and ACR data measured once (at baseline);
- 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.
- Signed informed consent form.
Exclusion Criteria:
- People with missing baseline biochemical data;
- Outliers in the population indicators, i.e., data deviating from the mean ± three times the standard deviation;
- 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 |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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The risk of rapid decline in kidney function in the elderly was assessed during a 2-year follow-up period
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY2024-1068
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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