KoreaN Cohort Study for Outcome in Pediatric Patients Wit... | NCT02165878

Studies
KoreaN Cohort Study for Outcome in Pediatric Patients With Chronic Kidney Disease

NCT02165878

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Sep 7, 2018Actual

Enrollment

458Actual

Phase

Not provided

Conditions

Chronic Kidney Disease(CKD)

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
KNOW-PedCKD	Other Identifier	Seoul National University Hospital

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011Actual

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2021Estimated

First Submitted Date

Jun 11, 2014

First Submission Date that Met QC Criteria

Jun 12, 2014

First Posted Date

Jun 18, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2018

Last Update Posted Date

Sep 7, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Il Soo Ha, Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Name	Class
Jeju National University Hospital	OTHER
Pusan National University Hospital	OTHER
Samsung Medical Center	OTHER
Kyungpook National University Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

458Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children and adolescent		children and adolescent CKD patients of any etiology

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Development of cardiovascular disease	Hypertrophy in g/m2	10 years
Metabolic bone disease	Bone Dexametry in z score	10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Dialysis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

CKD stage 1 through 5 Ages below 20

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Il Soo Ha, PhD	Seoul National University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41928132	Derived	Lim SH, Park E, Han KH, Song JY, Kim SH, Choi N, Cho H, Kim JY, Shin JI, Lee KH, Cho MH, Park MJ, Baek HS, Lee JH, Jung J, Yang EM, Kim JH, Ha IS, Kang HG, Ahn YH. Comparison of estimated and measured GFR in pediatric CKD patients transitioning from adolescence to adulthood: results from KNOW-PedCKD. BMC Nephrol. 2026 Apr 2;27(1):306. doi: 10.1186/s12882-026-04942-w.
34032031

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases