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

September 5, 2018 updated by: Il Soo Ha, Seoul National University Hospital

KoreaN Cohort Study for Outcome in Pediatric Patients With Chronic Kidney Disease : A 10-year Longitudinal Cohort Study of the Chronic Kidney Disease

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).

Study Overview

Status

Unknown

Conditions

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

Enrollment (Actual)

458

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

CKD stage 1 through 5 Ages below 20

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Dialysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
eGFR
Time Frame: 10 years
eGFR in mL/min/1.73 m2
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of cardiovascular disease
Time Frame: 10 years
Hypertrophy in g/m2
10 years
Metabolic bone disease
Time Frame: 10 years
Bone Dexametry in z score
10 years
Anemia
Time Frame: 10 years
Anemia in g/dL
10 years
Growth
Time Frame: 10 years
Height in z score
10 years
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™)
10 years
Cognitive skills and emotional development
Time Frame: 10 years
K-WAIS score
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Samsung Medical Center
Pusan National University Hospital
Asan Medical Center
Yonsei University
Kyungpook National University Hospital
Jeju National University Hospital

Investigators

  • Study Chair: Il Soo Ha, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2011

Primary Completion (Actual)

December 1, 2016

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

June 11, 2014

First Submitted That Met QC Criteria

June 12, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013E3301601
  • KNOW-PedCKD (Other Identifier: Seoul National University Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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