A Cohort Study on the Integrated Management of Chronic Kidney Disease
Starting soon
Conditions studied: Chronic Kidney Disease, Stage 5, Chronic Kidney Disease, Stage 4, Chronic Kidney Disease, Stage 3
In brief
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.
Key facts
- Study ID
- NCT07712341
- Run by
- Huashan Hospital
- People needed
- 4029
- Starts
- 2026-09-01
- Expected to finish
- 2028-08-30
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China
Full record on ClinicalTrials.gov
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