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Chonnam National University observational Cohort Study for Improved Outcomes in patients with Chronic Kidney Disease

Status Approved

  • First Submitted Date

    2021/01/07

  • Registered Date

    2021/02/04

  • Last Updated Date

    2021/09/29

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005865
    Unique Protocol ID CNUH-2020-391
    Public/Brief Title Chonnam National University observational Cohort Study for Improved Outcomes in patients with Chronic Kidney Disease
    Scientific Title Chonnam National University observational Cohort Study for Improved Outcomes in patients with Chronic Kidney Disease
    Acronym CONSERVE-CKD
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number CNUH-2020-391
    Approval Date 2021-01-06
    Institutional Review Board Name Chonnam National University Hospital Institutional review board
    Institutional Review Board Address 42, Jebongro, Donggu, Gwangju, Korea
    Institutional Review Board Telephone 062-220-5257
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Soo Wan Kim
    Title PI
    Telephone +82-62-220-6271
    Affiliation Chonnam National University Hospital
    Address 42, Jebongro, Donggu, Gwangju, Korea
    Contact Person for Public Queries
    Name TaeRyom Oh
    Title Assistant professor
    Telephone +82-62-220-6292
    Affiliation Chonnam National University Hospital
    Address 42, Jebongro, Donggu, Gwangju, Korea
    Contact Person for Updating Information
    Name TaeRyom Oh
    Title Co-PI
    Telephone +82-62-220-6292
    Affiliation Chonnam National University Hospital
    Address 42, Jebongro, Donggu, Gwangju, Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2021-10-01 Anticipated
    Target Number of Participant 4000
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Chonnam National University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2021-10-01 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ministry of Health & Welfare
    Organization Type Government
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Chonnam National University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    [Research Purpose]
    1) Collecting data on the clinical course of chronic kidney disease and disease progression
    2) Collecting data on the occurrence of end-stage renal failure, including the reduction of mortality, glomerular filtration rate and initiation of renal replacement therapy, and its impact on quality of life and mental health.
    3) Identify the factors that involved in the progression of chronic kidney disease
    4) Collecting data of complications of chronic kidney disease 
    5) Identify risk factors of complications development and predict high risk groups 
    6) Establishment of treatment guidelines including modification of lifestyle of patients with chronic kidney disease and medication
    
    [Research method]
    Considering the domestic situation in which the prevalence of chronic kidney disease increases due to the high aging index and the increase in the prevalence of diabetes and hypertension in the Gwangju/Jeonnam region, identification of clinical courses including changes in renal function, mortality and complications of chronic kidney disease is very important. In addition, it is of great significance to investigate the risk factors, biochemical indicators, and genetic factors which are related with chronic kidney disease. To achieve these goals, we will establish a cohort representing chronic kidney disease in Gwangju/Jeonnam region, and common guidelines for follow-up of cohort subjects.
    
    1) Study Design: Adult (19-79 years old) chronic kidney disease patient registration and chronic kidney disease cohort study
    2) Establishment of active follow-up system for patients undergoing nephrology treatment at Chonnam National University Hospital and investigation of factors related to complications and prognosis of chronic kidney disease
    3) Stable sample banking for the subject and establishment of storage systems for banking 
    4) Establishment of research infrastructure
    -Development of questionnaire, consent form, case record sheet, and follow-up observation sheet
    -Establishment of patient database
    
    [Expected results]
    1) Obtaining basic data on the clinical course, mortality rate, incidence of various complications, and risk factors of complications of chronic kidney disease in Koreans
    2) Statistical evidence on the effects of chronic kidney disease on public health, social and economic losses are presented.
    3) Identify risk factors for rapid progression of chronic kidney disease, and enable early detection of high-risk group and early intervention.
    4) Identify risk factors for various complications of chronic kidney disease, and enable early detection of high-risk group and early intervention.
    5) Provides data for diabetic kidney disease, the most common cause of chronic kidney disease and for early detection and management of various complications including cardiovascular complication which is most common cause of death.
    6) Suggestion of treatment guidelines including modification of lifestyle for patients with chronic kidney disease
    7) This database can be used as representative data for chronic kidney disease in Koreans, and can be used to establish international guidelines for chronic kidney disease.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Cohort
    Time Perspective Prospective  
    Target Number of Participant 4000
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Chronic Kidney Disease

    Cohort/Group Description

    [Baseline data on registration]
    1) Demographic data: date of birth, gender, contact information, smoking and drinking history
    2) Questionnaire:
    -Health questionnaire: Use a modified questionnaire form to apply chronic kidney disease.
    -KDQOL-SF36: Quality of life assessment
    -PHQ-9: Depression screening test
    3) medical history data
    -Causes of chronic kidney disease
    -History: cardiovascular disease, stroke, gestational diabetes, and high blood pressure (for women),
    -Family history: Diabetes. High blood pressure, cardiovascular disease, stroke
    -Medication history (within the last 1 month):
    Antihypertensive drugs, hypoglycemic drugs, hyperlipidemia drugs, NSAIDs, antibiotics, radiation contrast agents, phosphorus binding agents, vitamins, uric acid-lowering drugs such as allopurinol, iron, hematopoietic hormones
    4) blood pressure, heart rate
    5) Nutrition evaluation
    -7-point SGA (Subjective Global Assessment): nutritional assessment
    -Skinfold: abdominal, triceps
    -MAMC (mid arm muscle circumference): triceps
    -Hand grip test
    -Weight, height, BMI, waist circumference, hip circumference
    
    [Follow-up items]
    1) Recent events: dialysis/transplantation, cardiovascular complications, death, etc.
    2) Medication history (within the last 1 month):
    Antihypertensive drugs, hypoglycemic drugs, hyperlipidemia drugs, NSAIDs, antibiotics, radiation contrast agents, phosphorus binding agents, vitamins, uric acid-lowering drugs such as allopurinol, iron, hematopoietic hormones
    3) blood pressure, heart rate
    4) Nutritional evaluation: every 3 years
    -Skin fold: abdominal, triceps
    -MAMC (mid arm muscle circumference): triceps
    -Hand grip test
    -7-point SGA
        -Weight, height, BMI, waist circumference, hip circumference
    5) Health survey, QOL and PHQ-9: every 3 years or when outcome occurs
    Biospecimen
    Collection & Archiving
    : DNA Collect & Archive: Sample with DNA
    Biospecimen Description
    plasma, buffy coat. urine
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Adult chronic kidney disease patients aged 19-79
    Sampling Method
    Convenience sampling
    Condition(s)/Problem(s) * (N00-N99)Diseases of the genitourinary system 
       (N18.5)Chronic kidney disease, stage 5 

    Renal Insufficiency, Chronic
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~79Year

    Description

    1) Age 19-79
    2) Patients who qualify the criteria for diagnosis of chronic kidney disease based on KDIGO guidelines
    Exclusion Criteria
    1) Those who have undergone dialysis for more than 3 months in the past
    2) Those who received any organ transplantation
    3) Patients with a history of receiving cancer treatment or currently undergoing cancer treatment (can be enrolled in cases where 5 years have elapsed without evidence of cancer recurrence and a cure is determined)
    4) Pregnant women (however, registration is possible after 6 months of delivery)
    5) Persons with one kidney due to accident or provision of a transplanted kidney (in case of congenital single kidney or unilateral atrophic kidney, registration is possible)
    6) Those who refuse to provide consent for research, or who are unable to understand the research and voluntarily give consent
    7) Those who are difficult to participate in the research due to the judgment of other researchers
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome
    Dialysis, Kidney transplantations, eGFR declines ≥50% from baseline, Doubling of srum creatinine
    Timepoint
    evaluate on every visit
    Primary Outcome(s) 2
    Outcome
    MI, PCI or CABS, Stroke, Hospitalization for congestive heart failure
    Timepoint
    evaluate on every visit
    Primary Outcome(s) 3
    Outcome
    Death
    Timepoint
    evaluate on every visit
    Secondary Outcome(s) 1
    Outcome
    ABI-PWV, albuminuria, SGA score
    Timepoint
    ABI-PWV and  SGA score will be evaluated on every 3 years, albuminuria will be evaluated on every visit
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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