A Cohort Study on the Integrated Management of Chronic Kidney Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Retrospective data collection: Retrospective data from the maintenance hemodialysis cohort at Huashan Hospital (Sept 2018-Sept 2025) include: Demographics: age, sex, education, smoking/alcohol, primary disease, dialysis vintage. Dialysis treatment: repeated measures of weight, BP, heart rate, arterial/venous/transmembrane pressures, ultrafiltration rate, session time, dialyzer type, blood flow, and medications. Complication control:Nutrition: lipids, glucose, prealbumin, albumin, BMI, nPCR;Bone mineral: Ca, P, PTH, 25(OH)D₃;CVD: coronary calcification score, echocardiography, brain MRI, ECG;Inflammation: ferritin, CRP;Anemia: Hb, Fe, TIBC, TSAT;Acid-base \& electrolytes: CO₂CP, Mg, K, Na, Cl . Renal filtration:Cr, BUN, UA,β₂-MG, NT-proBNP, urine output. Neuropsychology: quality-of-life and symptom scores. Comorbidities: diabetes, CVD, hypertension,etc. Physical function: frailty score, ADL, comprehensive geriatric assessment. Medications: anticoagulants, ESA, etc. Diagnosis: ICD-10 codes, diagnosis date,etc.

Prospective data collection: Research data are primarily derived from the prospective CKD cohort at Huashan Hospital Integrated CKD Management Clinic. Baseline includes: age, sex, education, smoking/alcohol, primary disease. Follow-up (every 3 months): 3-day diet diary (via app/paper) to calculate P/Ca/protein intake; indirect calorimetry for resting energy expenditure; nutritional supplement use. Physical: handgrip, gait speed (sarcopenia), DEXA bone density. Questionnaires: frailty, ADL, QoL, symptom scores. Labs (repeated): bone mineral (Ca, P, PTH, 25-OH-D₃), CRP, anemia panel, small/middle toxins (Cr, BUN, UA, β₂-MG), BNP. Imaging: coronary calcification score, echocardiography, brain MRI (for cerebrovascular risk). Renal filtration: repeated Cr, BUN, UA, β₂-MG, NT-proBNP, urine output.

External validation: The research data are primarily based on the previously established community-based chronic kidney disease (CKD) cohort at Shanghai Fifth People's Hospital and the end-stage renal disease (ESRD) cohort at Shanghai Jing'an District Central Hospital, which serve as external validation and the data contents are the same as the retrospective data collection.

Study summary

The study will leverage the established multi-stage cohort resources at Huashan Hospital, covering the entire spectrum from early-stage CKD to dialysis, including a comorbidity real-world database, a prospective CKD patient cohort, and a maintenance hemodialysis patient real-world cohort. It will also collaborate with the Shanghai Fifth People's Hospital (community-based CKD cohort, n\>2,000) and the Jing'an District Central Hospital (end-stage renal disease cohort, n\>400) as external validation platforms. Using epidemiological and big data-driven approaches, the study aims to elucidate the mechanisms underlying disease progression and complications, construct intelligent intervention models, and validate their performance in the external cohorts, ultimately facilitating the optimization and broader application of comprehensive CKD management strategies.

Eligibility

Primary outcome measure(s)

• Significant decline in renal function — From baseline up to 7 years
  Significant decline in renal function:defined as rapid renal function decline events assessed by commonly used clinical indicators, including glomerular filtration rate (eGFR), comprising: (1) a sustained decrease in eGFR of ≥30% from baseline during follow-up; and (2) progression to end-stage renal disease (ESRD), defined as eGFR \< 15 mL/min/1.73 m² or initiation of maintenance dialysis.

Trial sites (1)

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