Clinical trial NCT02165878: KoreaN Cohort Study for Outcome in Pediatric Patients With Chronic Kidney Disease
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease(CKD)
Keywords: Chronic kidney disease(CKD)
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Jeju National University Hospital
name: Pusan National University Hospital
name: Samsung Medical Center
name: Kyungpook National University Hospital
name: Yonsei University
name: Asan Medical Center
First posted: 2014-06-18
Enrollment: 458
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CKD stage 1 through 5 Ages below 20

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- Dialysis

Primary outcomes:
measure: eGFR
timeFrame: 10 years
Secondary outcomes:
measure: Development of cardiovascular disease
timeFrame: 10 years
measure: Metabolic bone disease
timeFrame: 10 years
measure: Anemia
timeFrame: 10 years
measure: Growth
timeFrame: 10 years
measure: Health-related quality of life (HRQOL)
timeFrame: 10 years
measure: Cognitive skills and emotional development
timeFrame: 10 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Il Soo Ha, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.