NCT02042963

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.

Trial Health

55
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Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Last Updated

January 23, 2014

Status Verified

January 1, 2014

Enrollment Period

8.9 years

First QC Date

January 20, 2014

Last Update Submit

January 20, 2014

Conditions

Kidney Transplant RecipientsComplications After Kidney Transplant

Keywords

The cohort of Asian kidney transplant recipientsThe cohort of metabolic complication after kidney transplantThe biorepository of Asian kidney transplant recipients

Outcome Measures

Primary Outcomes (2)

  • overall mortality

    9 years

  • Allograft survival

    defined as re-transplant or initiation of maintenance dialysis

    9 years

Secondary Outcomes (5)

  • cardiovascular event

    9 years

  • Albuminuria

    9 years

  • Acute Rejection

    9 years

  • New onset of diabetes after transplant

    9 years

  • Quality of Life

    2 years

Study Arms (1)

KNOW-KT

1000 Kidney transplant recipients in Korea

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Recipients and Donors of kidney transplant

You may not qualify if:

  • Multi-organ transplant recipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National Univeristy Hospital

Seoul, South Korea

Location

Related Publications (3)

  • Jung HY, Jeon Y, Huh KH, Park JB, Kim MG, Lee S, Han S, Ro H, Yang J, Ahn C, Cho JH, Park SH, Kim YL, Kim CD. Pretransplant and Posttransplant Alcohol Consumption and Outcomes in Kidney Transplantation: A Prospective Multicenter Cohort Study. Transpl Int. 2022 May 30;35:10243. doi: 10.3389/ti.2022.10243. eCollection 2022.

    PMID: 35707634DERIVED

  • Hong N, Lee J, Kim HW, Jeong JJ, Huh KH, Rhee Y. Machine Learning-Derived Integer-Based Score and Prediction of Tertiary Hyperparathyroidism among Kidney Transplant Recipients: An Integer-Based Score to Predict Tertiary Hyperparathyroidism. Clin J Am Soc Nephrol. 2022 Jul;17(7):1026-1035. doi: 10.2215/CJN.15921221. Epub 2022 Jun 10.

    PMID: 35688469DERIVED

  • Yang J, Lee J, Huh KH, Park JB, Cho JH, Lee S, Ro H, Han SY, Kim YH, Jeong JC, Park BJ, Han DJ, Park SB, Chung W, Park SK, Kim CD, Kim SJ, Kim YS, Ahn C; KNOW-KT Study Group. KNOW-KT (KoreaN cohort study for outcome in patients with kidney transplantation: a 9-year longitudinal cohort study): study rationale and methodology. BMC Nephrol. 2014 May 9;15:77. doi: 10.1186/1471-2369-15-77.

    PMID: 24884405DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA, serum, urine, RNA (blood and urine)

Study Design

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

Study Record Dates

First Submitted

January 20, 2014

First Posted

January 23, 2014

Study Start

March 1, 2012

Primary Completion

February 1, 2021

Last Updated

January 23, 2014

Record last verified: 2014-01

Locations

KR(1)