KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease : A 10-year Longitudinal Cohort Study of the Chronic Kidney Disease (KNOW-CKD)

This study is currently recruiting participants.
Verified July 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Curie Ahn, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01630486
First received: June 26, 2012
Last updated: July 2, 2013
Last verified: July 2013

June 26, 2012
July 2, 2013
March 2011
December 2020   (final data collection date for primary outcome measure)
overall mortality [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01630486 on ClinicalTrials.gov Archive Site
  • cardiovascular event [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • renal replacement therapy [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    dialysis or kidney transplantation
  • doubling of serum creatinine [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease : A 10-year Longitudinal Cohort Study of the Chronic Kidney Disease
KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease

The goals of the 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 Research Group comprises nephrologists, pediatric nephrologists, epidemiologists and statisticians from eleven centers in Korea. KNOW-CKD will enroll 2,850 individuals with CKD stage from 1 to 5 between 2011 and 2015 and follow them up to 10 years. Dialyzed patients or those with allograft kidney are excluded. At enrollment and at pre-specified intervals, laboratory tests will be conducted on the kidney function, biochemical profiles, anemia, cardiovascular complication (echocardiography, coronary CT, arterial stiffness), and mineral bone disorder. A biobank is also established for the DNA, serum and urine at regular interval. Information on the medical history, health questionnaires, QoL will also be collected. Web-based case-report forms (CRF) is developed for the systemic management of the patient data.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

A biobank is also established for the DNA, serum and urine taken at regular interval.

Non-Probability Sample

CKD stage 1 through 5 Ages below 75

Chronic Kidney Disease
Not Provided
  • glomerulonephritis
    adult CKD patients, whose underlying etiology is glomerulonephritis, either clinically diagnosed or pathologically proven
  • hypertensive nephropathy
    adult CKD patients, whose underlying etiology is hypertensive nephropathy
  • polycystic kidney disease
    adult CKD patients, whose underlying etiology is autosomal dominant polycystic kidney disease
  • children and adolescent
    children and adolescent CKD patients of any etiology
  • diabetic nephropathy
    adult CKD patients, whose underlying etiology is diabetic nephropathy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2850
December 2021
December 2020   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age: <75 yr
  • CKD stage 1 through 5
  • predialysis

Exclusion Criteria:

  • Unable or unwilling to give consent
  • Previously received chronic dialysis
  • Previous any organ transplant
  • Heart failure
  • Known liver cirrhosis
  • past or current cancer
  • Pregnant women
  • Single kidney due to trauma or donation
Both
up to 75 Years
No
Contact: Kook-Hwan Oh, MD 82 2 2072 0776 khoh@snu.ac.kr
Contact: Seungmi Lee, BA 82 2 2072 1592 fairy2love@hanmail.net
Korea, Republic of
 
NCT01630486
KNOW-CKD
No
Curie Ahn, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP