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 June 2014 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Il Soo Ha, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02165878
First received: June 11, 2014
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

The goals of the KNOW-pedCKD (KoreaN cohort study for Outcome in Pediatric patients With Chronic Kidney Disease) study are 1) to establish a CKD cohort representing Korean pediatric 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-pedCKD Research Group comprises nephrologists, pediatric nephrologists, epidemiologists and statisticians from eleven centers in Korea. KNOW-pedCKD will enroll 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.


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:
  • Overall mortality [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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

  • Change in serum creatinine [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 300
Study Start Date: March 2011
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children and adolescent
children and adolescent CKD patients of any etiology

  Eligibility

Ages Eligible for Study:   up to 20 Years
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
  • predialysis

Exclusion Criteria:

  • Unable or unwilling to give consent
  • Previously received chronic dialysis
  • Previous any organ transplant
  • Heart failure
  • Past or current cancer
  • Single kidney due to trauma or donation
  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

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
  More Information

No publications provided

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: June 12, 2014
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 28, 2014