KoreaN Cohort Study for Outcome in Patients With Kidney T... | NCT02042963

Studies
KoreaN Cohort Study for Outcome in Patients With Kidney Transplantation (KNOW-KT)

NCT02042963

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Jan 23, 2014Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Kidney Transplant Recipients
Complications After Kidney Transplant

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Feb 2021Estimated

Completion Date

Not provided

First Submitted Date

Jan 20, 2014

First Submission Date that Met QC Criteria

Jan 20, 2014

First Posted Date

Jan 23, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2014

Last Update Posted Date

Jan 23, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Curie Ahn, Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Name	Class
Asan Medical Center	OTHER
Chonbuk National University Medical School	UNKNOWN
Gachon University Gil Medical Center	OTHER
Keimyung University Dongsan Medical Center

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

KNOW-KT (KoreaN cohort study for Outcome in patients With KT: A 9-year Longitudinal cohort study of the Korean adult KT patients), funded by Korea Center for Disease Control and Prevention (KCDC) was established in 2012 by a group of transplant physicians, transplant surgeons, nephrologists, epidemiologists, and biostatisticians in Korea.

We aimed to establish an adult KT cohort, to investigate the renal allograft outcomes, mortality, complications, and to explore traditional or nontraditional risk factors for morbidity and mortality. We established a bio-bank to integrate clinical and biological information. Here, we report design and method of the KNOW-KT.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

9 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Label	Type	Description	Intervention Names
KNOW-KT		1000 Kidney transplant recipients in Korea

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall mortality		9 years
Allograft survival	defined as re-transplant or initiation of maintenance dialysis	9 years

Secondary Outcomes

Measure	Description	Time Frame
cardiovascular event	Acute Myocardial Infarction Revascularization : PCI or CABG Stroke Admission from Congestive heart failure	9 years
Albuminuria		9 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recipients and Donors of kidney transplant

Exclusion Criteria:

Multi-organ transplant recipients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Kidney transplant recipients and their donors (donors for baseline data)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National Univeristy Hospital		Seoul			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42209439	Derived	Jung HY, Seo YJ, Huh KH, Park JB, Kim MG, Kang KP, Han S, Cho JH, Park SH, Kim CD, Kim YL, Ryu JH, Yang J. Self-Reported Sleep Duration, Death-Censored Graft Failure and Health-Related Quality of Life Among Kidney Transplant Recipients: Results From the KNOW-KT Study. Nephrology (Carlton). 2026 Jun;31(6):e70229. doi: 10.1111/nep.70229.
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