NCT06765811

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,539

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
Last Updated

January 9, 2025

Status Verified

July 1, 2024

Enrollment Period

11.5 years

First QC Date

January 5, 2025

Last Update Submit

January 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • A ≥30% decline in glomerular filtration rate (GFR) within 2 years, i.e. a rapid decline in renal function

    The risk of rapid decline in kidney function in the elderly was assessed during a 2-year follow-up period

Study Arms (2)

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.

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

kidney disease patient

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan hospital, Fudan university

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jing Chen, PhD, MD

    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

January 5, 2025

First Posted

January 9, 2025

Study Start

July 1, 2011

Primary Completion

December 25, 2022

Study Completion

December 25, 2022

Last Updated

January 9, 2025

Record last verified: 2024-07

Locations