Chronic Kidney Disease and Metabolic Disorders in the Elderly

NCT07494526 | Not Yet Recruiting

• 1 other identifier: 2024YFC3607400
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Chronic Kidney Diease; Diabetes Mellitus; Hyperlipidemia; Hyperuricemia; Hypertension

Keywords

chronic kidney disease; elderly; metabolic disorders

Outcome Measures

Primary Outcomes (3)

• 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.

  through study completion, an average of 1 year

• All-cause mortality

  From date of enrollment until death from any cause, assessed up to 5 years

• Progression to ESRD.

  From date of enrollment until progression to ESRD or death from any cause, whichever came first, assessed up to 5 years

Study Arms (2)

Sub-cohort 1 - Elderly Adults without chronic kidney disease (CKD) at Baseline

Sub-cohort 2 - Elderly Patients with chronic kidney disease (CKD)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may not qualify if:

• 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.
• Follow-up requirement meeting at least one of the following: At least one serum creatinine measurement with an interval of ≥ 6 months after baseline. Occurrence of a primary endpoint event (new-onset CKD).
• Presence of CKD at baseline, defined as: Glomerular filtration rate (eGFR) \< 60 ml/(min·1.73m²) or positive urine protein; or the presence of an ICD-10 diagnostic code for CKD in medical records.
• Baseline age ≥ 65 years.
• Meeting the diagnostic criteria for CKD: Glomerular filtration rate (eGFR) \< 60 ml/(min·1.73m²) or urine protein (UACR ≥ 30 mg/g); or based on ICD-10 codes.
• Baseline date requirement: Between January 1, 2010, and December 31, 2025.
• Follow-up requirement meeting at least one of the following:
• Occurrence of a primary endpoint event (mortality, ESRD); At least one serum creatinine measurement with an interval of ≥ 6 months after baseline.
• End-stage renal disease (ESRD) at baseline (eGFR \< 15 ml/(min·1.73m²), or prior receipt of kidney transplant or dialysis), based on ICD codes).
• Diagnosis of acute kidney injury (AKI) within the preceding 3 months.
• New York Heart Association (NYHA) Class III or IV heart failure or occurrence of acute myocardial infarction within the preceding 6 months.
• Child-Pugh Class B or C liver cirrhosis.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• 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 Chu Hsien-I Memorial Hospital: collaborator

Study Sites (2)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

chinese PLA general hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (1)

• Liu P, Sawhney S, Heide-Jorgensen U, Quinn RR, Jensen SK, Mclean A, Christiansen CF, Gerds TA, Ravani P. Predicting the risks of kidney failure and death in adults with moderate to severe chronic kidney disease: multinational, longitudinal, population based, cohort study. BMJ. 2024 Apr 15;385:e078063. doi: 10.1136/bmj-2023-078063.

  PMID: 38621801 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, urine

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Hyperlipidemias; Hyperuricemia; Renal Insufficiency, Chronic; Metabolic Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Central Study Contacts

Shuang Liang

CONTACT

86+15110246423; liangshuang301@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)