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A Cohort Study on the Integrated Management of Chronic Kidney Disease

2026年7月14日 更新者：Chen Jing、Huashan Hospital
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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This study is a multi-center, bidirectional cohort study. The research data are primarily derived from the multidisciplinary clinical cohort of chronic kidney disease (CKD) established by the Department of Nephrology at Huashan Hospital, Fudan University, and are supplemented by external validation platforms at Shanghai Fifth People's Hospital and Shanghai Jing'an District Central Hospital.

The study will systematically integrate and utilize the multidimensional cohort resources already established at Huashan Hospital, covering the entire spectrum from early-stage CKD to dialysis, including a real-world database of comorbid populations, a prospective cohort of CKD patients, and a real-world cohort of maintenance hemodialysis patients. Using epidemiological and big data-driven computational approaches, the study will focus on exploring comorbidity patterns associated with CKD and establishing an early classification and early warning system; it will also investigate the mechanisms underlying the progression of kidney disease and related complications such as cardiovascular disease, nutritional and metabolic abnormalities, and osteoporosis, and develop intelligent intervention models. Based on these findings, the study will propose the concept of metabolic balance and accordingly establish precision nutrition and drug evaluation protocols.

To ensure the generalizability and reliability of the research outcomes, this study will conduct external validation and effectiveness evaluation of the previously constructed comorbidity patterns, early warning system, and management protocols in the community-based CKD cohort (over 2,000 participants) at Shanghai Fifth People's Hospital and the end-stage renal disease cohort (over 400 participants) at Jing'an District Central Hospital. This will facilitate the widespread application and continuous optimization of the comprehensive CKD management program.

研究类型

观察性的

注册 (估计的)

4029

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200040
        • Huashan Hospital, Fudan University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

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.

描述

Inclusion Criteria:

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.

Exclusion Criteria:

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
AI model development
其他：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 nutritional intervention
其他：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
其他：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Significant decline in renal function
大体时间：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.
From baseline up to 7 years

次要结果测量

结果测量
措施说明
大体时间
Composite complications
大体时间：Up to 7 years from baseline
Composite complications include the composite outcomes of cardiovascular disease, nutritional and metabolic abnormalities, osteoporosis, and fractures related to chronic kidney disease. Specifically:Cardiovascular disease will be determined by combining imaging examinations (e.g., coronary artery calcium score, echocardiography, etc.) with clinical events.Osteoporosis and fractures will be diagnosed based on bone mineral density testing, imaging findings, and clinical fracture events.Nutritional and metabolic abnormalities will be diagnosed according to criteria from the International Society of Renal Nutrition and Metabolism (ISRNM) and other relevant standards, using indicators such as serum albumin, prealbumin, body mass index (BMI), and 3-day dietary intake assessments to diagnose protein-energy wasting (PEW) and mineral metabolism disorders.
Up to 7 years from baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Huashan Hospital

合作者

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

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2028年8月30日

研究完成 (估计的)

2028年8月30日

研究注册日期

首次提交

2026年7月14日

首先提交符合 QC 标准的

2026年7月14日

首次发布 (实际的)

2026年7月17日

研究记录更新

最后更新发布 (实际的)

2026年7月17日

上次提交的符合 QC 标准的更新

2026年7月14日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • KY-2026-706

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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