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Trial record 1 of 1 for:    NCT01630486
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KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease : A 10-year Longitudinal Cohort Study of the Chronic Kidney Disease (KNOW-CKD)

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ClinicalTrials.gov Identifier: NCT01630486
Recruitment Status : Active, not recruiting
First Posted : June 28, 2012
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Kook-Hwan Oh, Seoul National University Hospital

Tracking Information
First Submitted Date June 26, 2012
First Posted Date June 28, 2012
Last Update Posted Date June 5, 2019
Actual Study Start Date March 2011
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 27, 2012)
overall mortality [ Time Frame: 10 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01630486 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 27, 2012)
  • cardiovascular event [ Time Frame: 10 years ]
  • renal replacement therapy [ Time Frame: 10 years ]
    dialysis or kidney transplantation
  • doubling of serum creatinine [ Time Frame: 10 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease : A 10-year Longitudinal Cohort Study of the Chronic Kidney Disease
Official Title KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
A biobank is also established for the DNA, serum and urine taken at regular interval.
Sampling Method Non-Probability Sample
Study Population CKD stage 1 through 5 Ages below 75
Condition Chronic Kidney Disease
Intervention Not Provided
Study Groups/Cohorts
  • 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
  • diabetic nephropathy
    adult CKD patients, whose underlying etiology is diabetic nephropathy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: June 3, 2019)
2238
Original Estimated Enrollment
 (submitted: June 27, 2012)
2850
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age: >20 and <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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01630486
Other Study ID Numbers KNOW-CKD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kook-Hwan Oh, Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Seoul National University Hospital
Verification Date June 2019