NCT03929900

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started May 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
May 2019Dec 2026

First Submitted

Initial submission to the registry

April 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 4, 2019

Status Verified

June 1, 2019

Enrollment Period

7.6 years

First QC Date

April 25, 2019

Last Update Submit

June 3, 2019

Conditions

Chronic Kidney Diseases

Keywords

Renal progressionMortalityComplicationsRisk factors

Outcome Measures

Primary Outcomes (1)

  • Overall mortality

    all-cause death, cardiovascular death

    5 years

Secondary Outcomes (3)

  • Cardiovascular event

    5 years

  • Renal replacement therapy

    5 years

  • Doubling of serum creatinine or eGFR halving

    5 years

Eligibility Criteria

Age45 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age 45-79 years
  • Estimated glomerular filtration rate 20-60mL/min/1.73m2 based on CKD-EPI(Cr) equation
  • Non-dialysis dependent (NDD)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA, serum, plasma, random urine will be collected at pre-specified interval

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Kook-Hwan Oh, MD

CONTACT

82 2 2072 0776khoh@snu.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 25, 2019

First Posted

April 29, 2019

Study Start

May 15, 2019

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 4, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)