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NCT03929900Recruiting

KNOW-CKD Cohort, Phase II Study

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

Source: ClinicalTrials.gov · Last updated 4 Jun 2019 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1500 (estimated)
First submitted
25 Apr 2019
Start date
15 May 2019
Primary completion date
31 Dec 2026
Lead sponsor
Seoul National University Hospital
NCT number
NCT03929900

What you commit to

  • Study type: Observational
  • Planned participants: 1500
  • From 15 May 2019 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previously received chronic dialysis
  • Previous any organ transplant
  • Patients who received immunosuppressive agent within the past 1 year

Other illness

  • Autosomal dominant polycystic kidney disease
  • Patients who diagnosed heart failure with NYHA class 3 or 4

Other

  • Unable or unwilling to give consent
  • Known liver cirrhosis (Child-pugh class 2 or 3)
  • Pregnant women
  • Single kidney due to trauma or donation
  • Patients who diagnosed with glomerulonephritis through kidney biopsy

Who the study is looking for

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

Age in the registry: 45 years to 79 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Seoul National University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.