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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

KNOW-CKD Cohort, Phase II Study

Clinicaltrials.gov identifier NCT03929900

Recruitment Status Recruiting

First Posted April 29, 2019

Last update posted June 4, 2019

Study Description

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
  • Intervention/Treatment:
  • Phase: N/A
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.

Study Design
  • 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 2019
  • Estimated Primary Completion Date: December 2026
  • Estimated Study Completion Date: December 2026
Outcome Measures
  • 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

Eligibility Criteria
  • Ages Eligible for Study: 45 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

Contacts and Locations
Contacts

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

Locations

Korea, Republic of, Jongno-gu
Seoul National University Hospital
Seoul

Sponsors and Collaborators

Seoul National University Hospital

More Information
  • Responsible Party: 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Seoul National University Hospital: Renal progression
    Mortality
    Complications
    Risk factors
  • Additional relevant MeSH terms: Kidney Diseases Renal Insufficiency, Chronic