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KoreaN Cohort Study for Outcome in Pediatric Patients With Chronic Kidney Disease (KNOW-PedCKD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02165878
Recruitment Status : Active, not recruiting
First Posted : June 18, 2014
Last Update Posted : September 7, 2018
Sponsor:
Collaborators:
Jeju National University Hospital
Pusan National University Hospital
Samsung Medical Center
Kyungpook National University Hospital
Yonsei University
Asan Medical Center
Information provided by (Responsible Party):
Il Soo Ha, Seoul National University Hospital

Tracking Information
First Submitted Date June 11, 2014
First Posted Date June 18, 2014
Last Update Posted Date September 7, 2018
Actual Study Start Date March 2011
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 10, 2016)
eGFR [ Time Frame: 10 years ]
eGFR in mL/min/1.73 m2
Original Primary Outcome Measures
 (submitted: June 12, 2014)
Overall mortality [ Time Frame: 10 years ]
Change History
Current Secondary Outcome Measures
 (submitted: September 5, 2018)
  • Development of cardiovascular disease [ Time Frame: 10 years ]
    Hypertrophy in g/m2
  • Metabolic bone disease [ Time Frame: 10 years ]
    Bone Dexametry in z score
  • Anemia [ Time Frame: 10 years ]
    Anemia in g/dL
  • Growth [ Time Frame: 10 years ]
    Height in z score
  • Health-related quality of life (HRQOL) [ Time Frame: 10 years ]
    PedsQL 4.0 Generic Core Scale Module (Mapi Research Trust, on behalf of Dr James W. Varni, copyright owner of PedsQL™)
  • Cognitive skills and emotional development [ Time Frame: 10 years ]
    K-WAIS score
Original Secondary Outcome Measures
 (submitted: June 12, 2014)
  • Cardiovascular event [ Time Frame: 10 years ]
  • Renal replacement therapy [ Time Frame: 10 years ]
    dialysis or kidney transplantation
  • Change in serum creatinine [ Time Frame: 10 years ]
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 Pediatric Patients With Chronic Kidney Disease
Official Title KoreaN Cohort Study for Outcome in Pediatric Patients With Chronic Kidney Disease : A 10-year Longitudinal Cohort Study of the Chronic Kidney Disease
Brief Summary KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney Disease) is a nation-wide, ten-year longitudinal cohort study, launched in 2011. The aim of the study is to assess the characteristics and risk factors of progression and complications of CKD of Korea. Pediatric sub-cohort of KNOW-CKD is planned to enroll 450 children with CKD, stage I to V (pre-dialysis).
Detailed Description Seven major pediatric nephrology centers of Korea enrolled children younger than 20 years who had CKD. Medical history taking, questionaire assessment of socio-economic status, anthropometric measurement, and clinical assessment using laboratory and imaging tests were done. Outcome is development of LV hypertrophy or hypertension, growth, neuropsychological status, behavioral status, kidney growth, and quality of life.
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 Probability Sample
Study Population CKD stage 1 through 5 Ages below 20
Condition Chronic Kidney Disease(CKD)
Intervention Not Provided
Study Groups/Cohorts Children and adolescent
children and adolescent CKD patients of any etiology
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: October 23, 2016)
458
Original Estimated Enrollment
 (submitted: June 12, 2014)
300
Estimated Study Completion Date December 2021
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age: < 20 yr
  • CKD stage 1 through 5 of KDIGO guideline
  • predialysis

Exclusion Criteria:

- Dialysis

Sex/Gender
Sexes Eligible for Study: All
Ages up to 20 Years   (Child, 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 NCT02165878
Other Study ID Numbers 2013E3301601
KNOW-PedCKD ( Other Identifier: Seoul National University Hospital )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Il Soo Ha, Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators
  • Jeju National University Hospital
  • Pusan National University Hospital
  • Samsung Medical Center
  • Kyungpook National University Hospital
  • Yonsei University
  • Asan Medical Center
Investigators
Study Chair: Il Soo Ha, PhD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date September 2018