An observational study in Chronic Kidney Diease, Diabetes Mellitus and Hypertension, sponsored by Chinese PLA General Hospital. Not yet recruiting at 2 sites in China. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Chinese PLA General Hospital · Observational
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.
Background and Rationale Chronic kidney disease (CKD) complicated by metabolic disorders - including diabetes mellitus, hypertension, hyperlipidemia, hyperuricemia, and calcium-phosphorus disturbances - poses a significant public health threat to the elderly population. China is experiencing accelerating demographic aging, making the burden of CKD and metabolic comorbidity in older adults an increasingly pressing clinical and policy challenge.
Current clinical practice is often characterized by a fragmented approach in which multiple coexisting conditions are managed independently, without an integrated framework that accounts for their interactions. Furthermore, there is no international consensus on the diagnostic criteria, epidemiological characteristics, or prognostic assessment of CKD in the elderly.
Study Design
This is a multicenter, prospective and retrospective observational cohort study aiming to enroll a total of 100,000 elderly participants. The study comprises two sub-cohorts with distinct eligibility criteria and complementary scientific objectives:
Sub-cohort 1 - Incident CKD in Elderly Adults without CKD at Baseline:
Elderly individuals without CKD at baseline will be enrolled and followed longitudinally. Baseline and follow-up data will be collected to evaluate the impact of metabolic diseases (diabetes, hypertension, hyperlipidemia, hyperuricemia, calcium-phosphorus disorders) on the risk of incident CKD, major adverse cardiovascular events (MACE), and all-cause mortality. This sub-cohort will also be used to establish and validate age-appropriate diagnostic thresholds and criteria for CKD in the elderly Chinese population.
Sub-cohort 2 - Elderly CKD Patients with Metabolic Comorbidities:
Elderly patients with established CKD (stages 1-4, excluding stage 5 or those already on renal replacement therapy) will be enrolled. Baseline and longitudinal follow-up data will be used to characterize the comorbidity profile of elderly CKD patients in China, and to evaluate the effects of metabolic comorbidities on long-term outcomes, including all-cause mortality, progression to end-stage renal disease (ESRD), and cardiovascular events.
The objectives of this study are:
To describe the epidemiological characteristics and risk factor profiles of CKD-metabolic comorbidity in elderly adults in China.
To establish and validate age-appropriate diagnostic criteria and thresholds for CKD in the elderly.
To evaluate the prognostic impact of metabolic comorbidities on CKD-related outcomes.
To develop clinical decision-support tools applicable to community and home-based settings.
To provide evidence to inform the development and updating of relevant clinical guidelines.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 100,000 is above the median of 246 across 1,936 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Chinese PLA General Hospital is the lead sponsor of 570 studies on the registry; 207 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
For Sub-cohort 1, the inclusion and exclusion criteria are as follows:
Inclusion Criteria:
Exclusion Criteria:
Presence of CKD at baseline, defined as: (eGFR) \< 60 ml/(min·1.73m²) or positive urine protein; or the presence of an ICD-10 diagnostic code for CKD in medical records.
For Sub-cohort 2 (CKD Patients), the inclusion and exclusion criteria are as follows:
Inclusion Criteria:
Occurrence of a primary endpoint event (mortality, ESRD); At least one serum creatinine measurement with an interval of ≥ 6 months after baseline.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 year
All-cause mortality
Time frame: From date of enrollment until death from any cause, assessed up to 5 years
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 years
Plan to share: No — Individual participant data sharing is not planned at this time, due to Chinese regulations on personal information protection and human genetic resources management. Aggregated and de-identified data may be made available upon reasonable request, subject to regulatory approval.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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