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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Seoul National University Hospital
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
ClinicalTrials.gov Identifier:
NCT02165878
First received: June 11, 2014
Last updated: January 10, 2016
Last verified: January 2016
  Purpose
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
Chronic Kidney Disease(CKD)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • eGFR [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    eGFR in mL/min/1.73 m2


Secondary Outcome Measures:
  • Development of cardiovascular disease [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Hypertrophy in g/m2

  • Metabolic bone disease [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Bone Dexametry in z score

  • Anemia [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Anemia in g/dL

  • Growth [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Height in z score

  • Quality of life [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    Functioning score

  • Cognitive skills and emotional development [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    K-WAIS score


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

Estimated Enrollment: 450
Study Start Date: March 2011
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children and adolescent
children and adolescent CKD patients of any etiology

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.
  Eligibility

Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02165878

Contacts
Contact: Il Soo Ha, PhD 82-2-2072-3584 ilsooha@snu.ac.kr
Contact: Hee Gyung Kang, PhD pedneph@snuh.org

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Il Soo Ha    82-2-2072-3584    ilsooha@snu.ac.kr   
Contact: Hee Gyung Kang       pedneph@snuh.org   
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
  More Information

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 
Study First Received: June 11, 2014
Last Updated: January 10, 2016
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Chronic kidney disease(CKD)

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

ClinicalTrials.gov processed this record on July 21, 2016