How Metabolic Conditions Affect Kidney Disease Outcomes in Older Adults in China

Trial details

Who runs it

Chinese PLA General Hospital

Trial code

NCT07494526

Record updated

27 March 2026

Original description

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.Read full original descriptionShow less

Research on the Prevention, Control, and Intelligent Management Decision-Making for Comorbidities of Chronic Kidney Disease and Metabolic Disorders in the Elderly

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.

Inclusion: 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); 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.

Exclusion: New York Heart Association (NYHA) Class III or IV heart failure or occurrence of acute myocardial infarction within the preceding 6 months; Malignant neoplasm; 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; 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); For Sub-cohort 2 (CKD Patients), the inclusion and exclusion criteria are as follows:; Diagnosis of acute kidney injury (AKI) within the preceding 3 months; Child-Pugh Class B or C liver cirrhosis.

For Sub-cohort 1, the inclusion and exclusion criteria are as follows:.

ClinicalTrials.gov NCT07494526