NCT01630486

Brief 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 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.

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
2,238

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
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 5, 2019

Status Verified

June 1, 2019

Enrollment Period

11.8 years

First QC Date

June 26, 2012

Last Update Submit

June 3, 2019

Conditions

Chronic Kidney Disease

Keywords

renal progressionmortalitycomplicationsrisk factorsrole of biochemical parametersgenetic influence

Outcome Measures

Primary Outcomes (1)

  • overall mortality

    10 years

Secondary Outcomes (3)

  • cardiovascular event

    10 years

  • renal replacement therapy

    10 years

  • doubling of serum creatinine

    10 years

Study Arms (4)

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

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CKD stage 1 through 5 Ages below 75

You may qualify if:

  • Age: \>20 and \<75 yr,
  • CKD stage 1 through 5
  • predialysis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (11)

  • Park 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.

    PMID: 40478754DERIVED

  • Park 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.

    PMID: 35656977DERIVED

  • Kim 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.

    PMID: 34369187DERIVED

  • Lee 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.

    PMID: 33092438DERIVED

  • Kim 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.

    PMID: 30943913DERIVED

  • Chae 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.

    PMID: 30595681DERIVED

  • Kang 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.

    PMID: 30115015DERIVED

  • Kim 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.

    PMID: 29506503DERIVED

  • Lee 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.

    PMID: 27884313DERIVED

  • Han 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.

    PMID: 26430892DERIVED

  • Oh 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.

    PMID: 24884708DERIVED

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 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 26, 2012

First Posted

June 28, 2012

Study Start

March 1, 2011

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

June 5, 2019

Record last verified: 2019-06

Locations

KR(1)