A Cohort Study on the Integrated Management of Chronic Kidney Disease

NCT07712341 | Not Yet Recruiting

• 1 other identifier: KY-2026-706
• Study Type: observational
• Target: 4,029
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease, Stage 5; Chronic Kidney Disease, Stage 4; Chronic Kidney Disease, Stage 3

Keywords

Chronic Kidney Disease; dialysis

Outcome Measures

Primary Outcomes (1)

• Significant decline in renal function

  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.

  From baseline up to 7 years

Secondary Outcomes (1)

• Composite complications

  Up to 7 years from baseline

Study Arms (3)

AI model development

Other: Retrospective data collection

Prospective nutritional intervention

Other: Prospective data collection

External validation

Other: External validation

Interventions

Retrospective data collection OTHER

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.

AI model development

External validation OTHER

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.

External validation

Prospective data collection OTHER

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.

Prospective nutritional intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study data originate from the real-world comorbidity database (covering 48 common chronic diseases) built from Huashan Hospital's inpatient EMR system, the real-world maintenance hemodialysis cohort based on China's first hemodialysis information management system at Huashan, the prospective CKD cohort from Huashan's integrated nephrology clinic, as well as the community CKD cohort from Shanghai Fifth People's Hospital and the ESRD cohort from Jing'an District Central Hospital for external validation.

You may qualify if:

• Prospective:
• Patients who have documented outpatient or inpatient records at Huashan Hospital, Shanghai Fifth People's Hospital, or Jing'an District Central Hospital during the period from September 2018 to September 2025.
• Aged 18-90 years.
• Diagnosed with one or more of the 48 pre-specified common chronic diseases according to ICD-10 codes.
• Patients diagnosed with end-stage renal disease (CKD stage 5) and receiving long-term maintenance hemodialysis, with a dialysis vintage of at least 3 months.
• Have relatively complete hemodialysis records available at the participating center.
• Retrospective:
• Patients who meet the diagnostic criteria for chronic kidney disease (CKD) stages 1-5 (non-dialysis) as defined by the KDIGO guidelines, with a disease duration of at least 3 months.
• Aged 18-80 years, with normal cognitive ability to independently, or with the assistance of a caregiver, complete dietary diaries and quantitative assessments, and willing to provide written informed consent voluntarily.
• Able to comply with regular outpatient follow-up visits and willing to record a 3-day dietary diary (including both weekdays and weekends) as required.

You may not qualify if:

• Prospective:
• Patients whose dialysis-related data and key clinical variables (e.g., creatinine, proteinuria, and other outcome-related indicators) are missing or severely illogical, and which are deemed unusable for research purposes upon evaluation.
• Patients with poor compliance during dialysis, or those receiving palliative dialysis.
• Other conditions that the investigators consider inappropriate.
• Retrospective:
• Patients who have experienced acute kidney injury within 3 months prior to enrollment, or who are in an acute stress state such as acute infection, myocardial infarction, or other acute conditions at the time of screening.
• Patients with severe cognitive impairment, mental illness, or insurmountable communication barriers that prevent accurate provision of metabolic assessment information.
• Pregnant or lactating women; patients currently participating in other drug interventional clinical trials that may interfere with the outcome assessment of this study.

Sponsors & Collaborators

• Huashan Hospital: lead
• Jingan District Central Hospital of Shanghai (Jingan Branch of Huashan Hospital Affiliated to Fudan University): collaborator
• Fudan University Affiliated Shanghai Fifth People's Hospital Hospital: collaborator

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jing Chen

CONTACT

862152888050; chenjing1998@fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Physician

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)