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

Study Overview
=================
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.

Official Title
-----------------
KoreaN Cohort Study for Outcome in Patients With Chronic Kidney Disease

Conditions
-----------------
Chronic Kidney Disease

Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| glomerulonephritis<br>adult CKD patients, whose underlying etiology is glomerulonephritis, either clinically diagnosed or pathologically proven | |
| hypertensive nephropathy<br>adult CKD patients, whose underlying etiology is hypertensive nephropathy | |
| polycystic kidney disease<br>adult CKD patients, whose underlying etiology is autosomal dominant polycystic kidney disease | |
| diabetic nephropathy<br>adult CKD patients, whose underlying etiology is diabetic nephropathy | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall mortality |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular event |  | 10 years | 
| renal replacement therapy | dialysis or kidney transplantation | 10 years | 
| doubling of serum creatinine |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal progression, mortality, complications, risk factors, role of biochemical parameters, genetic influence