Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03929900

KNOW-CKD Cohort, Phase II Study

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

45 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location status: Recruiting

Location contact

Kook-Hwan Oh, MD

CONTACT

[email protected]

82 2 2072 0776

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall mortality

    Time frame: 5 years

    all-cause death, cardiovascular death

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Kook-Hwan Oh, MD

CONTACT

[email protected]

82 2 2072 0776

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2019
Registry last updated
Jun 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.