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

Chronic Kidney Disease(CKD) Clinical Trial

— KNOW-PedCKD  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02165878
• Other study ID #: 2013E3301601
• Secondary ID: KNOW-PedCKD
• Status: Active, not recruiting
• Start date: March 2011
• Est. completion date: December 2021

Study information

• Verified date: September 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 458
• Est. completion date: December 2021
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 20 Years

Eligibility

Inclusion Criteria:

• Age: < 20 yr

• CKD stage 1 through 5 of KDIGO guideline

• predialysis

Exclusion Criteria:

• Dialysis

Related Conditions & MeSH terms

• Chronic Kidney Disease(CKD)
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (7)

Lead Sponsor	Collaborator
Seoul National University Hospital	Asan Medical Center, Jeju National University Hospital, Kyungpook National University, Pusan National University Hospital, Samsung Medical Center, Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eGFR	eGFR in mL/min/1.73 m2	10 years
Secondary	Development of cardiovascular disease	Hypertrophy in g/m2	10 years
Secondary	Metabolic bone disease	Bone Dexametry in z score	10 years
Secondary	Anemia	Anemia in g/dL	10 years
Secondary	Growth	Height in z score	10 years
Secondary	Health-related quality of life (HRQOL)	PedsQL 4.0 Generic Core Scale Module (Mapi Research Trust, on behalf of Dr James W. Varni, copyright owner of PedsQL™)	10 years
Secondary	Cognitive skills and emotional development	K-WAIS score	10 years