Chronic Kidney Disease Clinical Trial
— KNOW-CKDOfficial title:
KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease
| Verified date | June 2019 |
| Source | Seoul National University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 2238 |
| Est. completion date | December 2022 |
| Est. primary completion date | December 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul National University Hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Hospital |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | overall mortality | 10 years | ||
| Secondary | cardiovascular event | 10 years | ||
| Secondary | renal replacement therapy | dialysis or kidney transplantation | 10 years | |
| Secondary | doubling of serum creatinine | 10 years |
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