NCT02165878

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
458

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

5.8 years

First QC Date

June 11, 2014

Last Update Submit

September 5, 2018

Conditions

Chronic Kidney Disease(CKD)

Keywords

Chronic kidney disease(CKD)

Outcome Measures

Primary Outcomes (1)

  • eGFR

    eGFR in mL/min/1.73 m2

    10 years

Secondary Outcomes (6)

  • Development of cardiovascular disease

    10 years

  • Metabolic bone disease

    10 years

  • Anemia

    10 years

  • Growth

    10 years

  • Health-related quality of life (HRQOL)

    10 years

  • +1 more secondary outcomes

Study Arms (1)

Children and adolescent

children and adolescent CKD patients of any etiology

Eligibility Criteria

AgeUp to 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

CKD stage 1 through 5 Ages below 20

You may qualify if:

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

You may not qualify if:

  • \- Dialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (4)

  • Kang NR, Ahn YH, Park E, Lee KH, Baek HS, Kim SH, Cho H, Cho MH, Shin JI, Lee JH, Cheong HI, Kang HG, Park YS, Ha IS, Moon DS, Han KH. Intellectual Functioning of Pediatric Patients with Chronic Kidney Disease: Results from the KNOW-Ped CKD. J Korean Med Sci. 2021 May 24;36(20):e138. doi: 10.3346/jkms.2021.36.e138.

    PMID: 34032031DERIVED

  • Baek HS, Kim SH, Kang HG, Choi HJ, Cheong HI, Ha IS, Han KH, Cho HY, Shin JI, Park YS, Lee JH, Ahn YH, Park E, Cho MH. Dyslipidemia in pediatric CKD patients: results from KNOW-PedCKD (KoreaN cohort study for Outcomes in patients With Pediatric CKD). Pediatr Nephrol. 2020 Aug;35(8):1455-1461. doi: 10.1007/s00467-020-04545-z. Epub 2020 Mar 30.

    PMID: 32232640DERIVED

  • Kang NR, Ahn YH, Park E, Choi HJ, Kim SH, Cho H, Cho MH, Shin JI, Lee JH, Park YS, Cheong HI, Kang HG, Ha IS, Kwack YS, Han KH. Mental health and psychosocial adjustment in pediatric chronic kidney disease derived from the KNOW-Ped CKD study. Pediatr Nephrol. 2019 Oct;34(10):1753-1764. doi: 10.1007/s00467-019-04292-w. Epub 2019 Jun 20.

    PMID: 31222663DERIVED

  • Kang HG, Choi HJ, Han KH, Kim SH, Cho HY, Cho MH, Shin JI, Lee JH, Lee J, Oh KH, Park YS, Cheong HI, Ahn C, Ha IS. KNOW-Ped CKD (KoreaN cohort study for outcomes in patients with pediatric CKD): Design and methods. BMC Nephrol. 2016 Mar 25;17:35. doi: 10.1186/s12882-016-0248-0.

    PMID: 27012243DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Il Soo Ha, PhD

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 11, 2014

First Posted

June 18, 2014

Study Start

March 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2021

Last Updated

September 7, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)