Tacrolimus Exposure in Kidney Transplantation

NCT ID: NCT06348446

Last Updated: 2024-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

12000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2024-08-30

Brief Summary

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Using CDW data from 5 tertiary hospitals in Korea, this study identify the optimal range of trough level that can prevent adverse outcome in the early periods after transplantation.

Detailed Description

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Conditions

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Kidney Transplant Rejection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Renal transplant recipients between January 1, 2005 through December 31, 2014 in one of the five participating centers
* Patients receiving oral tacrolimus as one of the main immunosuppressant at the start of the defined cohort time (i.e. at post-transplant 2 months for the analysis of 1-year outcomes and at post-transplant 12 months for the analysis of 6-year outcomes)

Exclusion Criteria

* Graft failure occurring within the first 2 month of transplantation
* Mortality of any cause occurring within the first 2 month of transplantation
* Patients moving centers during the study period
* Patients who have received other organ transplantation(s) besides renal transplantation in the defined period
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Asan medical center, Seoul, Korea

Seoul, , South Korea

Site Status RECRUITING

Samsung medical center, Seoul, Korea

Seoul, , South Korea

Site Status RECRUITING

Seoul St. Mary's hospital, Seoul, Korea

Seoul, , South Korea

Site Status RECRUITING

Severance hospital, Seoul, Korea

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sangil Min

Role: CONTACT

01071739341

Facility Contacts

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Young Hoon Kim, MD

Role: primary

82-10-2705-6998

Jae Berm Park, MD

Role: primary

82-10-8971-1953

Sun Cheol Park, MD

Role: primary

82-10-6310-2847

kyuha Hur, MD

Role: primary

82-10-2043-9947

Other Identifiers

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FY20-2963

Identifier Type: -

Identifier Source: org_study_id

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