Chronic Kidney DiseaseKNOW-CKDNCT01630486
KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease : A 10-year Longitudinal Cohort Study of the Chronic Kidney Disease
An observational study of Chronic Kidney Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The goals of the KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney Disease) study are 1) to establish a CKD cohort representing Korean CKD population for up to 10-year follow-up, and 2) to investigate the renal progression, mortality, complications, risk factors, role of biochemical parameters… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 2,238 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2011to Dec 2022
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CKD stage 1 through 5 Ages below 75
Who may be able to join
- Age: >20 and <75 yr,
- CKD stage 1 through 5
- predialysis
Who cannot join
- Unable or unwilling to give consent
- Previously received chronic dialysis
- Previous any organ transplant
- Heart failure
- Known liver cirrhosis
- past or current cancer
- Pregnant women
- Single kidney due to trauma or donation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease
The goals of the KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney Disease) study are 1) to establish a CKD cohort representing Korean CKD population for up to 10-year follow-up, and 2) to investigate the renal progression, mortality, complications, risk factors, role of biochemical parameters and the genetic influence.
KNOW-CKD Research Group comprises nephrologists, pediatric nephrologists, epidemiologists and statisticians from eleven centers in Korea. KNOW-CKD will enroll 2,850 individuals with CKD stage from 1 to 5 between 2011 and 2015 and follow them up to 10 years. Dialyzed patients or those with allograft kidney are excluded. At enrollment and at pre-specified intervals, laboratory tests will be conducted on the kidney function, biochemical profiles, anemia, cardiovascular complication (echocardiography, coronary CT, arterial stiffness), and mineral bone disorder. A biobank is also established for the DNA, serum and urine at regular interval. Information on the medical history, health questionnaires, QoL will also be collected. Web-based case-report forms (CRF) is developed for the systemic management of the patient data.
- Conditions
- Chronic Kidney Disease
- Keywords
- renal progression, mortality, complications, risk factors, role of biochemical parameters, genetic influence
- 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 |
|---|---|---|
| glomerulonephritis | adult CKD patients, whose underlying etiology is glomerulonephritis, either clinically diagnosed or pathologically proven | |
| hypertensive nephropathy | adult CKD patients, whose underlying etiology is hypertensive nephropathy | |
| polycystic kidney disease | adult CKD patients, whose underlying etiology is autosomal dominant polycystic kidney disease | |
| diabetic nephropathy | adult CKD patients, whose underlying etiology is diabetic nephropathy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall mortality
Measured: 10 years
Secondary outcomes (3)
cardiovascular event
Measured: 10 years
renal replacement therapy
dialysis or kidney transplantation
Measured: 10 years
doubling of serum creatinine
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 posted28 Jun 2012 (estimated)
- Study startMar 2011
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies 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
- 2,238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kook-Hwan Oh, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630486
- Sponsor's protocol ID
- KNOW-CKD
- Acronym
- KNOW-CKD
- Status last verified
- Jun 2019
- First submitted
- 26 Jun 2012
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Park CH, Hong HJ, Kim HW, Park JT, Chang TI, Yoo TH, Park SK, Kim JS, Lee KB, Jeong JC, Oh KH, Anderson AH, Yang W, Cohen JB, Rahman M, Kang SW, Han SH; On the behalf of CRIC Study and KNOW-CKD Investigators. Proteinuria and Kidney Function Trajectories in Patients with Advanced CKD: Insights from Chronic Renal Insufficiency Cohort and Korean Cohort Study for Outcome in Patients with CKD Studies. Clin J Am Soc Nephrol. 2026 Aug 27. doi: 10.2215/CJN.0000001206. Online ahead of print.
PubMed 42658641Kim M, An S, Ryu H, Sun C, An HY, Ryu G, Kim J, Kim Y, Kim SW, Kim YH, Jaiswal S, Koh Y, Oh KH. Clonal Hematopoiesis of Indeterminate Potential and Kidney Failure in CKD: An East Asian Cohort Study. Clin J Am Soc Nephrol. 2026 Aug 1;21(8):1340-1351. doi: 10.2215/CJN.0000001092. Epub 2026 Jun 11.
PubMed 42275156Park CH, Kim HW, Park JT, Chang TI, Yoo TH, Oh KH, Anderson AH, Yang W, Cohen JB, Rahman M, Kang SW, Han SH; on the behalf of CRIC Study and KNOW-CKD Investigators. BP and Kidney Disease Progression in Advanced CKD: Findings from the Chronic Renal Insufficiency Cohort and KoreaN Cohort Study for Outcome in Patients with CKD Studies. Clin J Am Soc Nephrol. 2025 Jun 6;20(9):1179-1189. doi: 10.2215/CJN.0000000760.
PubMed 40478754Park CH, Kim HW, Joo YS, Park JT, Chang TI, Yoo TH, Park SK, Chae DW, Chung W, Kim YS, Oh KH, Kang SW, Han SH; on the behalf of the KNOW-CKD (Korean Cohort Study for Outcomes in Patients With Chronic Kidney Disease) Investigators. Association Between Systolic Blood Pressure Variability and Major Adverse Cardiovascular Events in Korean Patients With Chronic Kidney Disease: Findings From KNOW-CKD. J Am Heart Assoc. 2022 Jun 7;11(11):e025513. doi: 10.1161/JAHA.122.025513. Epub 2022 Jun 3.
PubMed 35656977Kim JY, Park JT, Kim HW, Chang TI, Kang EW, Ahn C, Oh KH, Lee J, Chung W, Kim YS, Kim SW, Yoo TH, Kang SW, Han SH; KNOW-CKD (Korean Cohort Study for Outcomes in Patients With Chronic Kidney Disease) Investigators. Inflammation Alters Relationship Between High-Density Lipoprotein Cholesterol and Cardiovascular Risk in Patients With Chronic Kidney Disease: Results From KNOW-CKD. J Am Heart Assoc. 2021 Aug 17;10(16):e021731. doi: 10.1161/JAHA.120.021731. Epub 2021 Aug 7.
PubMed 34369187Lee C, Park KH, Joo YS, Nam KH, Chang TI, Kang EW, Lee J, Oh YK, Jung JY, Ahn C, Lee KB, Park JT, Yoo TH, Kang SW, Han SH. Low High-Sensitivity C-Reactive Protein Level in Korean Patients With Chronic Kidney Disease and Its Predictive Significance for Cardiovascular Events, Mortality, and Adverse Kidney Outcomes: Results From KNOW-CKD. J Am Heart Assoc. 2020 Nov 3;9(21):e017980. doi: 10.1161/JAHA.120.017980. Epub 2020 Oct 23.
PubMed 33092438Kim HJ, Lee J, Chae DW, Lee KB, Sung SA, Yoo TH, Han SH, Ahn C, Oh KH. Serum klotho is inversely associated with metabolic syndrome in chronic kidney disease: results from the KNOW-CKD study. BMC Nephrol. 2019 Apr 3;20(1):119. doi: 10.1186/s12882-019-1297-y.
PubMed 30943913Chae SY, Chung W, Kim YH, Oh YK, Lee J, Choi KH, Ahn C, Kim YS. The Correlation of Serum Osteoprotegerin with Non-Traditional Cardiovascular Risk Factors and Arterial Stiffness in Patients with Pre-Dialysis Chronic Kidney Disease: Results from the KNOW-CKD Study. J Korean Med Sci. 2018 Dec 11;33(53):e322. doi: 10.3346/jkms.2018.33.e322. eCollection 2018 Dec 31.
PubMed 30595681Kang E, Lee J, Kim HJ, Han M, Kim SW, Lee KB, Sung S, Yoo TH, Chung W, Ahn C, Oh KH. The association between socioeconomic disparities and left ventricular hypertrophy in chronic kidney disease: results from the KoreaN Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD). BMC Nephrol. 2018 Aug 16;19(1):203. doi: 10.1186/s12882-018-1005-3.
PubMed 30115015Kim HJ, Kang E, Oh YK, Kim YH, Han SH, Yoo TH, Chae DW, Lee J, Ahn C, Oh KH. The association between soluble klotho and cardiovascular parameters in chronic kidney disease: results from the KNOW-CKD study. BMC Nephrol. 2018 Mar 5;19(1):51. doi: 10.1186/s12882-018-0851-3.
PubMed 29506503Lee MJ, Park JT, Park KS, Kwon YE, Han SH, Kang SW, Choi KH, Oh KH, Park SK, Chae DW, Lee K, Hwang YH, Kim SW, Kim YH, Kang SW, Lee J, Ahn C, Yoo TH. Normal body mass index with central obesity has increased risk of coronary artery calcification in Korean patients with chronic kidney disease. Kidney Int. 2016 Dec;90(6):1368-1376. doi: 10.1016/j.kint.2016.09.011.
PubMed 27884313Han JS, Lee MJ, Park KS, Han SH, Yoo TH, Oh KH, Park SK, Lee J, Hyun YY, Chung W, Kim YH, Ahn C, Choi KH. Albuminuria as a Risk Factor for Anemia in Chronic Kidney Disease: Result from the KoreaN Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD). PLoS One. 2015 Oct 2;10(10):e0139747. doi: 10.1371/journal.pone.0139747. eCollection 2015.
PubMed 26430892Oh KH, Park SK, Park HC, Chin HJ, Chae DW, Choi KH, Han SH, Yoo TH, Lee K, Kim YS, Chung W, Hwang YH, Kim SW, Kim YH, Kang SW, Park BJ, Lee J, Ahn C; Representing KNOW-CKD Study Group. KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney Disease): design and methods. BMC Nephrol. 2014 May 19;15:80. doi: 10.1186/1471-2369-15-80.
PubMed 24884708
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01630486
- Acronym / sponsor ID
- KNOW-CKD / KNOW-CKD
- Conditions
- Chronic Kidney Disease
- Keywords
- renal progression, mortality, complications, risk factors, role of biochemical parameters, genetic influence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,238 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 28 Jun 2012 (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.
The goals of the KNOW-CKD (KoreaN cohort study for Outcome in patients With Chronic Kidney Disease) study are 1) to establish a CKD cohort representing Korean CKD population for up to 10-year follow-up, and 2) to investigate the renal progression, mortality, complications, risk factors, role of biochemical parameters and the genetic influence.
KNOW-CKD Research Group comprises nephrologists, pediatric nephrologists, epidemiologists and statisticians from eleven centers in Korea. KNOW-CKD will enroll 2,850 individuals with CKD stage from 1 to 5 between 2011 and 2015 and follow them up to 10 years. Dialyzed patients or those with allograft kidney are excluded. At enrollment and at pre-specified intervals, laboratory tests will be conducted on the kidney function, biochemical profiles, anemia, cardiovascular complication (echocardiography, coronary CT, arterial stiffness), and mineral bone disorder. A biobank is also established for the DNA, serum and urine at regular interval. Information on the medical history, health questionnaires, QoL will also be collected. Web-based case-report forms (CRF) is developed for the systemic management of the patient data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| glomerulonephritis | – | –adult CKD patients, whose underlying etiology is glomerulonephritis, either clinically diagnosed or pathologically proven |
| hypertensive nephropathy | – | –adult CKD patients, whose underlying etiology is hypertensive nephropathy |
| polycystic kidney disease | – | –adult CKD patients, whose underlying etiology is autosomal dominant polycystic kidney disease |
| diabetic nephropathy | – | –adult CKD patients, whose underlying etiology is diabetic nephropathy |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CKD stage 1 through 5 Ages below 75
Key inclusion criteria (3 listed)
- Age: >20 and <75 yr,
- CKD stage 1 through 5
- predialysis
Key exclusion criteria (8 listed)
- Unable or unwilling to give consent
- Previously received chronic dialysis
- Previous any organ transplant
- Heart failure
- Known liver cirrhosis
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
overall mortality
Time frame: 10 years
3 secondary outcomes
cardiovascular event
Time frame: 10 years
renal replacement therapy
Time frame: 10 years
doubling of serum creatinine
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 5 Jun 2019.
- Derived from this study: PubMed 42658641Park CH, Hong HJ, Kim HW, Park JT, Chang TI, Yoo TH, Park SK, Kim JS, Lee KB, Jeong JC, Oh KH, Anderson AH, Yang W, Cohen JB, Rahman M, Kang SW, Han SH; On the behalf of CRIC Study and KNOW-CKD Investigators. Proteinuria and Kidney Function Trajectories in Patients with Advanced CKD: Insights from Chronic Renal Insufficiency Cohort and Korean Cohort Study for Outcome in Patients with CKD Studies. Clin J Am Soc Nephrol. 2026 Aug 27. doi: 10.2215/CJN.0000001206. Online ahead of print.
- Derived from this study: PubMed 42275156Kim M, An S, Ryu H, Sun C, An HY, Ryu G, Kim J, Kim Y, Kim SW, Kim YH, Jaiswal S, Koh Y, Oh KH. Clonal Hematopoiesis of Indeterminate Potential and Kidney Failure in CKD: An East Asian Cohort Study. Clin J Am Soc Nephrol. 2026 Aug 1;21(8):1340-1351. doi: 10.2215/CJN.0000001092. Epub 2026 Jun 11.
- Derived from this study: PubMed 40478754Park CH, Kim HW, Park JT, Chang TI, Yoo TH, Oh KH, Anderson AH, Yang W, Cohen JB, Rahman M, Kang SW, Han SH; on the behalf of CRIC Study and KNOW-CKD Investigators. BP and Kidney Disease Progression in Advanced CKD: Findings from the Chronic Renal Insufficiency Cohort and KoreaN Cohort Study for Outcome in Patients with CKD Studies. Clin J Am Soc Nephrol. 2025 Jun 6;20(9):1179-1189. doi: 10.2215/CJN.0000000760.
- Derived from this study: PubMed 35656977Park CH, Kim HW, Joo YS, Park JT, Chang TI, Yoo TH, Park SK, Chae DW, Chung W, Kim YS, Oh KH, Kang SW, Han SH; on the behalf of the KNOW-CKD (Korean Cohort Study for Outcomes in Patients With Chronic Kidney Disease) Investigators. Association Between Systolic Blood Pressure Variability and Major Adverse Cardiovascular Events in Korean Patients With Chronic Kidney Disease: Findings From KNOW-CKD. J Am Heart Assoc. 2022 Jun 7;11(11):e025513. doi: 10.1161/JAHA.122.025513. Epub 2022 Jun 3.
- Derived from this study: PubMed 34369187Kim JY, Park JT, Kim HW, Chang TI, Kang EW, Ahn C, Oh KH, Lee J, Chung W, Kim YS, Kim SW, Yoo TH, Kang SW, Han SH; KNOW-CKD (Korean Cohort Study for Outcomes in Patients With Chronic Kidney Disease) Investigators. Inflammation Alters Relationship Between High-Density Lipoprotein Cholesterol and Cardiovascular Risk in Patients With Chronic Kidney Disease: Results From KNOW-CKD. J Am Heart Assoc. 2021 Aug 17;10(16):e021731. doi: 10.1161/JAHA.120.021731. Epub 2021 Aug 7.
- Derived from this study: PubMed 33092438Lee C, Park KH, Joo YS, Nam KH, Chang TI, Kang EW, Lee J, Oh YK, Jung JY, Ahn C, Lee KB, Park JT, Yoo TH, Kang SW, Han SH. Low High-Sensitivity C-Reactive Protein Level in Korean Patients With Chronic Kidney Disease and Its Predictive Significance for Cardiovascular Events, Mortality, and Adverse Kidney Outcomes: Results From KNOW-CKD. J Am Heart Assoc. 2020 Nov 3;9(21):e017980. doi: 10.1161/JAHA.120.017980. Epub 2020 Oct 23.
- Derived from this study: PubMed 30943913Kim HJ, Lee J, Chae DW, Lee KB, Sung SA, Yoo TH, Han SH, Ahn C, Oh KH. Serum klotho is inversely associated with metabolic syndrome in chronic kidney disease: results from the KNOW-CKD study. BMC Nephrol. 2019 Apr 3;20(1):119. doi: 10.1186/s12882-019-1297-y.
- Derived from this study: PubMed 30595681Chae SY, Chung W, Kim YH, Oh YK, Lee J, Choi KH, Ahn C, Kim YS. The Correlation of Serum Osteoprotegerin with Non-Traditional Cardiovascular Risk Factors and Arterial Stiffness in Patients with Pre-Dialysis Chronic Kidney Disease: Results from the KNOW-CKD Study. J Korean Med Sci. 2018 Dec 11;33(53):e322. doi: 10.3346/jkms.2018.33.e322. eCollection 2018 Dec 31.
- Derived from this study: PubMed 30115015Kang E, Lee J, Kim HJ, Han M, Kim SW, Lee KB, Sung S, Yoo TH, Chung W, Ahn C, Oh KH. The association between socioeconomic disparities and left ventricular hypertrophy in chronic kidney disease: results from the KoreaN Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD). BMC Nephrol. 2018 Aug 16;19(1):203. doi: 10.1186/s12882-018-1005-3.
- Derived from this study: PubMed 29506503Kim HJ, Kang E, Oh YK, Kim YH, Han SH, Yoo TH, Chae DW, Lee J, Ahn C, Oh KH. The association between soluble klotho and cardiovascular parameters in chronic kidney disease: results from the KNOW-CKD study. BMC Nephrol. 2018 Mar 5;19(1):51. doi: 10.1186/s12882-018-0851-3.
- Derived from this study: PubMed 27884313Lee MJ, Park JT, Park KS, Kwon YE, Han SH, Kang SW, Choi KH, Oh KH, Park SK, Chae DW, Lee K, Hwang YH, Kim SW, Kim YH, Kang SW, Lee J, Ahn C, Yoo TH. Normal body mass index with central obesity has increased risk of coronary artery calcification in Korean patients with chronic kidney disease. Kidney Int. 2016 Dec;90(6):1368-1376. doi: 10.1016/j.kint.2016.09.011.
- Derived from this study: PubMed 26430892Han JS, Lee MJ, Park KS, Han SH, Yoo TH, Oh KH, Park SK, Lee J, Hyun YY, Chung W, Kim YH, Ahn C, Choi KH. Albuminuria as a Risk Factor for Anemia in Chronic Kidney Disease: Result from the KoreaN Cohort Study for Outcomes in Patients With Chronic Kidney Disease (KNOW-CKD). PLoS One. 2015 Oct 2;10(10):e0139747. doi: 10.1371/journal.pone.0139747. eCollection 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 8 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 5 Jun 2019. 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?
overall mortality (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 NCT01630486, which also lists 13 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 5 Jun 2019.