Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

A Cohort Study on the Integrated Management of Chronic Kidney Disease

14 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

4029

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chine, 200040
        • Huashan Hospital, Fudan University
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
AI model development
Autre: 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
Autre: 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
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Significant decline in renal function
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Composite complications
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Huashan Hospital

Collaborateurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

30 août 2028

Achèvement de l'étude (Estimé)

30 août 2028

Dates d'inscription aux études

Première soumission

14 juillet 2026

Première soumission répondant aux critères de contrôle qualité

14 juillet 2026

Première publication (Réel)

17 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • KY-2026-706

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner