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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02042963
Other study ID # KNOW-KT
Secondary ID
Status Enrolling by invitation
Phase N/A
First received January 20, 2014
Last updated January 20, 2014
Start date March 2012

Study information

Verified date January 2014
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Centers for Disease Control and Prevention
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1000
Est. completion date
Est. primary completion date February 2021
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Recipients and Donors of kidney transplant

Exclusion Criteria:

- Multi-organ transplant recipients

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Korea, Republic of Seoul National Univeristy Hospital Seoul

Sponsors (11)

Lead Sponsor Collaborator
Seoul National University Hospital Asan Medical Center, Chonbuk National University Medical School, Gachon University Gil Medical Center, Keimyung University Dongsan Medical Center, Korea University, Kyungpook National University, Medical Research Collaborating Center, Seoul, Korea, Samsung Medical Center, Seoul National University College of Medicine, Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary overall mortality 9 years No
Primary Allograft survival defined as re-transplant or initiation of maintenance dialysis 9 years No
Secondary cardiovascular event Acute Myocardial Infarction Revascularization : PCI or CABG Stroke Admission from Congestive heart failure 9 years No
Secondary Albuminuria 9 years No
Secondary Acute Rejection 9 years No
Secondary New onset of diabetes after transplant 9 years No
Secondary Quality of Life 2 years No
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