KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease : A 10-year Longitudinal Cohort Study of the Chronic Kidney Disease (KNOW-CKD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Curie Ahn, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01630486
First received: June 26, 2012
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition
Chronic Kidney Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • overall mortality [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cardiovascular event [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • renal replacement therapy [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    dialysis or kidney transplantation

  • doubling of serum creatinine [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

A biobank is also established for the DNA, serum and urine taken at regular interval.


Estimated Enrollment: 2550
Study Start Date: March 2011
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

CKD stage 1 through 5 Ages below 75

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630486

Contacts
Contact: Kook-Hwan Oh, MD 82 2 2072 0776 khoh@snu.ac.kr
Contact: Seungmi Lee, BA 82 2 2072 1592 fairy2love@hanmail.net

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Kook-Hwan Oh, DM    82-2-2072-0776    khoh@snu.ac.kr; ohchris@hanmail.net   
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Curie Ahn, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01630486     History of Changes
Other Study ID Numbers: KNOW-CKD
Study First Received: June 26, 2012
Last Updated: June 23, 2014
Health Authority: Korea Food and Drug Administration (KFDA): Republic of Korea

Keywords provided by Seoul National University Hospital:
renal progression
mortality
complications
risk factors
role of biochemical parameters
genetic influence

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on August 28, 2014