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

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ClinicalTrials.gov Identifier: NCT02165878
Recruitment Status : Active, not recruiting
First Posted : June 18, 2014
Last Update Posted : July 6, 2017
Sponsor:
Collaborators:
Jeju National University Hospital
Pusan National University Hospital
Samsung Medical Center
Kyungpook National University
Yonsei University
Asan Medical Center
Information provided by (Responsible Party):
Il Soo Ha, Seoul National University Hospital

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).

Condition or disease
Chronic Kidney Disease(CKD)

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
Actual Enrollment : 458 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : March 2011
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Group/Cohort
Children and adolescent
children and adolescent CKD patients of any etiology



Primary Outcome Measures :
  1. eGFR [ Time Frame: 10 years ]
    eGFR in mL/min/1.73 m2


Secondary Outcome Measures :
  1. Development of cardiovascular disease [ Time Frame: 10 years ]
    Hypertrophy in g/m2

  2. Metabolic bone disease [ Time Frame: 10 years ]
    Bone Dexametry in z score

  3. Anemia [ Time Frame: 10 years ]
    Anemia in g/dL

  4. Growth [ Time Frame: 10 years ]
    Height in z score

  5. Quality of life [ Time Frame: 10 years ]
    Functioning score

  6. Cognitive skills and emotional development [ Time Frame: 10 years ]
    K-WAIS score


Biospecimen Retention:   Samples With DNA
A biobank is also established for the DNA, serum and urine taken at regular interval.


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
CKD stage 1 through 5 Ages below 20
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Dialysis


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02165878


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Jeju National University Hospital
Pusan National University Hospital
Samsung Medical Center
Kyungpook National University
Yonsei University
Asan Medical Center
Investigators
Study Chair: Il Soo Ha, PhD Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Il Soo Ha, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02165878     History of Changes
Other Study ID Numbers: 2013E3301601
KNOW-PedCKD ( Other Identifier: Seoul National University Hospital )
First Posted: June 18, 2014    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Il Soo Ha, Seoul National University Hospital:
Chronic kidney disease(CKD)

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency