Chronic Kidney Disease and Metabolic Disorders in the Elderly
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorChinese PLA General Hospital
About this trial
The goal of this observational study is to investigate the impact of metabolic comorbidities on outcomes in elderly Chinese adults, through two parallel sub-cohorts: one comprising elderly individuals without chronic kidney disease (CKD) at baseline, and one comprising elderly patients with established CKD.
The main questions it aims to answer are:
Do metabolic diseases (diabetes, hypertension, hyperlipidemia, hyperuricemia, calcium-phosphorus disorders) increase the risk of incident CKD, major adverse cardiovascular events (MACE), and all-cause mortality in elderly individuals without CKD at baseline? What are the optimal diagnostic thresholds and criteria for CKD in the elderly population? How do metabolic comorbidities affect long-term outcomes - including all-cause mortality, end-stage renal disease (ESRD), and cardiovascular events - in elderly patients with established CKD? What is the comorbidity profile and disease burden of elderly CKD patients in China?
Participants in both sub-cohorts will:
Undergo baseline assessments including laboratory tests and clinical evaluations.
Provide longitudinal follow-up data through scheduled clinic visits and medical record linkage.
Contribute to a large-scale cohort of 100,000 elderly participants across multiple centers in China.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Baseline age ≥ 65 years.
Availability of baseline data on serum creatinine and at least one urinary protein measurement.
Urinary protein measurements include: UACR, UPCR, 24-hour urine protein quantification, and urine protein dipstick test.
Baseline date requirement: Between January 1, 2010, and December 31, 2025.
Trial population
Participants will be recruited from multiple clinical and community-based settings across China, through a network of tertiary hospitals and affiliated community health centers. The study population consists of elderly adults aged 60 years and older, divided into two sub-cohorts: Sub-cohort 1: Elderly individuals without CKD at baseline, recruited from community health centers and outpatient clinics. Sub-cohort 2: Elderly patients with established CKD, recruited from participating tertiary hospitals. Participants are drawn from geographically diverse regions of China, contributing to a nationally representative sample of the elderly population with and without chronic kidney disease.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
100,000 Participants
are grouped into 2 trial groupsGroup A: Sub-cohort 1 - Elderly Adults without chronic kidney disease (CKD) at Baseline
Group B: Sub-cohort 2 - Elderly Patients with chronic kidney disease (CKD)
Trial outcomes
Primary outcomes
1
incident CKD
For Sub-cohort 1 in Elderly Adults without CKD at Baseline, the primary outcome is incident CKD, which is defined as glomerular filtration rate (eGFR) \< 60 ml/(min·1.73m²) or positive urine protein; or the presence of a clear ICD-10 diagnostic code for CKD in medical records.
Time frame
through study completion, an average of 1 year2
All-cause mortality
Time frame
From date of enrollment until death from any cause, assessed up to 5 years3
Progression to ESRD.
Time frame
From date of enrollment until progression to ESRD or death from any cause, whichever came first, assessed up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chinese PLA General Hospital
Lead sponsor
Fudan University
Collaborator
Beijing Chao Yang Hospital
Collaborator
The First Affiliated Hospital of Dalian Medical University
Collaborator
Beijing Luhe Hospital
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Shandong Provincial Hospital
Collaborator
Second Xiangya Hospital of Central South University
Collaborator
Tianjin Medical University
Collaborator
Source ClinicalTrials.gov
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