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KNOW-CKD Cohort, Phase II Study

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ClinicalTrials.gov Identifier: NCT03929900
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Kook-Hwan Oh, Seoul National University Hospital

Brief Summary:

The goals of KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney Disease) study are 1) to establish a CKD cohort representing Korean CKD population for up to 10-year follow-up, and 2) to investigate the renal progression, mortality, complications, risk factors, role of biochemical parameters and the genetic influence. KNOW-CKD Phase I has enrolled 2,238 patients and these patients were divided into four major subgroups depending on the specific causes of CKD : glomerulonephritis, diabetic nephropathy, hypertensive nephropathy, and polycystic kidney disease. In progress, renal progression, complications, and cardiovascular disease of these patients are followed up now.

Since there was a lack of information related to patients' lifestyle, it is necessary to conduct various studies that can be applied to actual clinical status through evaluation of nutrition, cognitive functions, and lifestyles of patients with CKD in South Korea. In addition, researches for high risk patients including diabetic nephropathy, advanced CKD and elderly patients are needed. Thus, KNOW-CKD phase II will enroll the CKD subjects at a more advanced-stage, and older patients than KNOW-CKD phase I subjects.

KNOW-CKD phase II Investigator Group comprises nephrologists, epidemiologists and statisticians from multi-centers in South Korea. KNOW-CKD phase II will enroll 1,500 individuals with estimated glomerular filtration rate between 20 and 60mL/min/1.73m2 (CKD-EPI[Cr] equation) between 2019 and 2021 and follow them until 2016 (for 5~7 years). Unlike phase I, patients diagnosed with glomerulonephritis and ADPKD will be excluded in Phase II.


Condition or disease
Chronic Kidney Diseases

Detailed Description:
At enrollment and at pre-specified intervals, laboratory tests will be conducted on the kidney function, biochemical profiles, and anemia. Nutritional evaluation through skin fold, hand grip test, bioelectrical impedence analysis, and 7-point subjective global assessment (SGA), food frequency questionnaire (FFQ) will be conducted in a subgroup of patients. Information on the medical history, health questionnaires, QOL, K-MoCA will also be collected. Web-based case-report forms (CRF) will be used for the systematic management of the patient data.

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease: A Longitudinal Cohort Study of the Chronic Kidney Disease (KNOW-CKD), Phase II Study
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases




Primary Outcome Measures :
  1. Overall mortality [ Time Frame: 5 years ]
    all-cause death, cardiovascular death


Secondary Outcome Measures :
  1. Cardiovascular event [ Time Frame: 5 years ]
    major cardiovascular event (MACE)

  2. Renal replacement therapy [ Time Frame: 5 years ]
    end-stage renal disease : dialysis or kidney transplantation

  3. Doubling of serum creatinine or eGFR halving [ Time Frame: 5 years ]
    Doubling of serum creatinine or eGFR halving


Biospecimen Retention:   Samples With DNA
DNA, serum, plasma, random urine will be collected at pre-specified interval


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
non-dialysis-dependent, advanced CKD stage between 45 -79 years
Criteria

Inclusion Criteria:

  • Age 45-79 years
  • Estimated glomerular filtration rate 20-60mL/min/1.73m2 based on CKD-EPI(Cr) equation
  • Non-dialysis dependent (NDD)

Exclusion Criteria:

  • Autosomal dominant polycystic kidney disease
  • Unable or unwilling to give consent
  • Previously received chronic dialysis
  • Previous any organ transplant
  • Patients who diagnosed heart failure with NYHA class 3 or 4
  • Known liver cirrhosis (Child-pugh class 2 or 3)
  • Pregnant women
  • Single kidney due to trauma or donation
  • Patients who received immunosuppressive agent within the past 1 year
  • Patients who diagnosed with glomerulonephritis through kidney biopsy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929900


Contacts
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Contact: Kook-Hwan Oh, MD 82 2 2072 0776 khoh@snu.ac.kr

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Jongno-gu, Korea, Republic of, 03080
Contact: Kook-Hwan Oh, MD    82 2 2072 0776    khoh@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital

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Responsible Party: Kook-Hwan Oh, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03929900     History of Changes
Other Study ID Numbers: KNOW-CKD2
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kook-Hwan Oh, Seoul National University Hospital:
Renal progression
Mortality
Complications
Risk factors

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency