Chronic Kidney Disease(CKD)KNOW-PedCKDNCT02165878
KoreaN Cohort Study for Outcome in Pediatric Patients With Chronic Kidney Disease
An observational study of Chronic Kidney Disease(CKD), run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Chronic Kidney Disease(CKD)
- How many people
- 458 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2011to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: CKD stage 1 through 5 Ages below 20
Who may be able to join
- Age: < 20 yr
- CKD stage 1 through 5 of KDIGO guideline
- predialysis
Who cannot join
- Dialysis
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Chronic Kidney Disease(CKD)
- Keywords
- Chronic kidney disease(CKD)
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children and adolescent | children and adolescent CKD patients of any etiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
eGFR
eGFR in mL/min/1.73 m2
Measured: 10 years
Secondary outcomes (6)
Development of cardiovascular disease
Hypertrophy in g/m2
Measured: 10 years
Metabolic bone disease
Bone Dexametry in z score
Measured: 10 years
Anemia
Anemia in g/dL
Measured: 10 years
Growth
Height in z score
Measured: 10 years
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™)
Measured: 10 years
Cognitive skills and emotional development
K-WAIS score
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startMar 2011
- Primary completionDec 2016
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease(CKD)Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jeju National University Hospital, Pusan National University Hospital, Samsung Medical Center, Kyungpook National University Hospital, Yonsei University, Asan Medical Center
- Responsible party
- Principal investigator, Il Soo Ha, Seoul National University Hospital
- Investigators
- Il Soo Ha, PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165878
- Sponsor's protocol ID
- 2013E3301601
- Other IDs
- KNOW-PedCKD
- Acronym
- KNOW-PedCKD
- Status last verified
- Sep 2018
- First submitted
- 11 Jun 2014
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 41928132Kang 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.
PubMed 34032031Baek 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.
PubMed 32232640Kang 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.
PubMed 31222663Kang 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.
PubMed 27012243
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02165878
- Acronym / sponsor ID
- KNOW-PedCKD / 2013E3301601
- Conditions
- Chronic Kidney Disease(CKD)
- Keywords
- Chronic kidney disease(CKD)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Jeju National University Hospital, Pusan National University Hospital, Samsung Medical Center, Kyungpook National University Hospital, Yonsei University, Asan Medical Center
- Study start
- Mar 2011 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 18 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and adolescent | – | –children and adolescent CKD patients of any etiology |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- CKD stage 1 through 5 Ages below 20
Key inclusion criteria (3 listed)
- Age: < 20 yr
- CKD stage 1 through 5 of KDIGO guideline
- predialysis
Key exclusion criteria (1 listed)
- Dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
eGFR
Time frame: 10 years
eGFR in mL/min/1.73 m2
6 secondary outcomes
Development of cardiovascular disease
Time frame: 10 years
Metabolic bone disease
Time frame: 10 years
Anemia
Time frame: 10 years
Growth
Time frame: 10 years
Health-related quality of life (HRQOL)
Time frame: 10 years
Cognitive skills and emotional development
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Derived from this study: PubMed 41928132Lim 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.
- Derived from this study: PubMed 34032031Kang 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.
- Derived from this study: PubMed 32232640Baek 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.
- Derived from this study: PubMed 31222663Kang 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.
- Derived from this study: PubMed 27012243Kang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Il Soo Ha, PhD study chair
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease(CKD), run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eGFR (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02165878, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.