KNOW-CKD Cohort, Phase II Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

• Study Contact: Name: Kook-Hwan Oh, MD; Phone Number: 82 2 2072 0776; Email: khoh@snu.ac.kr

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Recruiting
      • Seoul National University Hospital
      • Contact: Kook-Hwan Oh, MD; Phone Number: 82 2 2072 0776; Email: khoh@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

non-dialysis-dependent, advanced CKD stage between 45 -79 years

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall mortality	all-cause death, cardiovascular death	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular event	major cardiovascular event (MACE)	5 years
Renal replacement therapy	end-stage renal disease : dialysis or kidney transplantation	5 years
Doubling of serum creatinine or eGFR halving	Doubling of serum creatinine or eGFR halving	5 years

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Anticipated): December 31, 2026
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Actual): June 4, 2019
• Last Update Submitted That Met QC Criteria: June 3, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Risk factors; Complications; Mortality; Renal progression
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: KNOW-CKD2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No