KNOW-CKD Cohort, Phase II Study

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03929900
• Other study ID #: KNOW-CKD2
• Status: Recruiting
• Start date: May 15, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2019
• Source: Seoul National University Hospital
• Contact: Kook-Hwan Oh, MD
• Phone: 82 2 2072 0776
• Email: khoh[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goals of 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 Phase I has enrolled 2,238 patients and these patients were divided into four major subgroups depending on the specific causes of CKD : glomerulonephritis, diabetic nephropathy, hypertensive nephropathy, and polycystic kidney disease. In progress, renal progression, complications, and cardiovascular disease of these patients are followed up now.

Since there was a lack of information related to patients' lifestyle, it is necessary to conduct various studies that can be applied to actual clinical status through evaluation of nutrition, cognitive functions, and lifestyles of patients with CKD in South Korea. In addition, researches for high risk patients including diabetic nephropathy, advanced CKD and elderly patients are needed. Thus, KNOW-CKD phase II will enroll the CKD subjects at a more advanced-stage, and older patients than KNOW-CKD phase I subjects.

KNOW-CKD phase II Investigator Group comprises nephrologists, epidemiologists and statisticians from multi-centers in South Korea. KNOW-CKD phase II will enroll 1,500 individuals with estimated glomerular filtration rate between 20 and 60mL/min/1.73m2 (CKD-EPI[Cr] equation) between 2019 and 2021 and follow them until 2016 (for 5~7 years). Unlike phase I, patients diagnosed with glomerulonephritis and ADPKD will be excluded in Phase II.

Description:

At enrollment and at pre-specified intervals, laboratory tests will be conducted on the kidney function, biochemical profiles, and anemia. Nutritional evaluation through skin fold, hand grip test, bioelectrical impedence analysis, and 7-point subjective global assessment (SGA), food frequency questionnaire (FFQ) will be conducted in a subgroup of patients. Information on the medical history, health questionnaires, QOL, K-MoCA will also be collected. Web-based case-report forms (CRF) will be used for the systematic management of the patient data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 79 Years

Eligibility

Inclusion Criteria:

• Age 45-79 years

• Estimated glomerular filtration rate 20-60mL/min/1.73m2 based on CKD-EPI(Cr) equation

• Non-dialysis dependent (NDD)

Exclusion Criteria:

• Autosomal dominant polycystic kidney disease

• Unable or unwilling to give consent

• Previously received chronic dialysis

• Previous any organ transplant

• Patients who diagnosed heart failure with NYHA class 3 or 4

• Known liver cirrhosis (Child-pugh class 2 or 3)

• Pregnant women

• Single kidney due to trauma or donation

• Patients who received immunosuppressive agent within the past 1 year

• Patients who diagnosed with glomerulonephritis through kidney biopsy

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall mortality	all-cause death, cardiovascular death	5 years
Secondary	Cardiovascular event	major cardiovascular event (MACE)	5 years
Secondary	Renal replacement therapy	end-stage renal disease : dialysis or kidney transplantation	5 years
Secondary	Doubling of serum creatinine or eGFR halving	Doubling of serum creatinine or eGFR halving	5 years