Kidney Function DeclineNCT06765811
Rapid Kidney Function Decline in Older Adults
An observational study of Kidney Function Decline and Glomerular Filtration Rate, run by Huashan Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Kidney Function Decline, Glomerular Filtration Rate, Urine Albumin-creatinine Ratio
- How many people
- 1,539 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2011to 25 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: kidney disease patient
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan hospital, Fudan university
Shanghai, Shanghai Municipality, 200040
About this study
Official title: 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.
- Conditions
- Kidney Function Decline, Glomerular Filtration Rate, Urine Albumin-creatinine Ratio, Healthy Aging, Comorbidity, Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
A ≥30% decline in glomerular filtration rate (GFR) within 2 years, i.e. a rapid decline in renal function
Measured: The risk of rapid decline in kidney function in the elderly was assessed during a 2-year follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Jul 2011
- Primary completion25 Dec 2022
- Study completion25 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Function DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,539 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Jing, Huashan Hospital
- Investigators
- Jing Chen, PhD, MD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765811
- Sponsor's protocol ID
- KY2024-1068
- Status last verified
- Jul 2024
- First submitted
- 5 Jan 2025
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Rapid Kidney Function Decline in Older Adults with Different Types of Aging
- ClinicalTrials.gov ID
- NCT06765811
- Acronym / sponsor ID
- KY2024-1068
- Conditions
- Kidney Function Decline, Glomerular Filtration Rate, Urine Albumin-creatinine Ratio, Healthy Aging, Comorbidity, Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,539 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2011 (actual)
- Primary completion
- 25 Dec 2022 (actual)
- Study completion
- 25 Dec 2022 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- kidney disease patient
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Chen, PhD, MD principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Function Decline and Glomerular Filtration Rate, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025; AzTrials last refreshed its copy on 29 Oct 2026.