Chronic Kidney Disease, Stage 5NCT07712341
A Cohort Study on the Integrated Management of Chronic Kidney Disease
An observational study of Chronic Kidney Disease, Stage 5 and Chronic Kidney Disease, Stage 4, run by Huashan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Kidney Disease, Stage 5, Chronic Kidney Disease, Stage 4, Chronic Kidney Disease, Stage 3
- What is being tested?
- Retrospective data collection, Prospective data collection and External validation
- How many people
- 4,029 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 30 Aug 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Jing (靖) Chen, 862152888050, chenjing1998@fudan.edu.cn
About this study
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.
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease, Stage 5, Chronic Kidney Disease, Stage 4, Chronic Kidney Disease, Stage 3
- Being tested
- Retrospective data collection, Prospective data collection, External validation
- Keywords
- Chronic Kidney Disease, dialysis
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective data collectionOther
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 collectionOther
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 validationOther
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 group | Role | What they receive |
|---|---|---|
| AI model development | Not described Receives: Other: Retrospective data collection | |
| Prospective nutritional intervention | Not described Receives: Other: Prospective data collection | |
| External validation | Not described Receives: Other: External validation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline up to 7 years
Secondary outcomes (1)
Composite complications
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.
Measured: Up to 7 years from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease, Stage 5Studies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 4,029 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jingan District Central Hospital of Shanghai (Jingan Branch of Huashan Hospital Affiliated to Fudan University), Fudan University
- Responsible party
- Principal investigator, Chen Jing, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712341
- Sponsor's protocol ID
- KY-2026-706
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study on the Integrated Management of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07712341
- Acronym / sponsor ID
- KY-2026-706
- Conditions
- Chronic Kidney Disease, Stage 5, Chronic Kidney Disease, Stage 4, Chronic Kidney Disease, Stage 3
- Keywords
- Chronic Kidney Disease, dialysis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,029 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Jingan District Central Hospital of Shanghai (Jingan Branch of Huashan Hospital Affiliated to Fudan University), Fudan University
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AI model development | – | Other: Retrospective data collection |
| Prospective nutritional intervention | – | Other: Prospective data collection |
| External validation | – | Other: External validation |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective data collectionRetrospective 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. | Other | AI model development |
| Prospective data collectionResearch 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. | Other | Prospective nutritional intervention |
| External validationThe 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. | Other | External validation |
Primary outcome
Significant decline in renal function
Time frame: 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.
1 secondary outcome
Composite complications
Time frame: Up to 7 years from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, Stage 5 and Chronic Kidney Disease, Stage 4, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Chen (862152888050, chenjing1998@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant decline in renal function (time frame: From baseline up to 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.