Tacrolimus Exposure in Kidney Transplantation

Seoul National University Hospital12,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

12,000

Conditions

Kidney Transplant Rejection

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (4)

Asan medical center, Seoul, Korea

Seoul, South Korea

RECRUITING

Samsung medical center, Seoul, Korea

Seoul, South Korea

RECRUITING

Seoul St. Mary's hospital, Seoul, Korea

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

relationship between time varying periodic mean of tacrolimus trough and a composite 1-year allograft outcomes

the relationship between time varying periodic mean of tacrolimus trough level during 2-12 mo. post-transplant and a composite of 1-year allograft outcomes consisting of biopsy proven acute rejection, renal dysfunction (eGFR\<30), development of dnDSA, and death censored graft failure that occurred within 1 year from the latest transplant.

Time frame: 1 year after transplantation

Secondary Outcomes

relationship between time varying periodic mean of tacrolimus trough level during 12-72 mo. post-transplant and 6-year composite allograft outcome

the relationship between time varying periodic mean of tacrolimus trough level during 12-72 mo. post-transplant and 6-year composite allograft outcome that occurred within 6 years from the latest transplant

Time frame: 6 year after transplantation

relationship between post-transplant time varying periodic mean tacrolimus trough level and severe infection

the relationship between post-transplant time varying periodic mean tacrolimus trough level and severe infection (1-year and 6-year)

Time frame: 6 year after transplantation

relationship between post-transplant time varying periodic mean tacrolimus trough level and cardiovascular event

the relationship between post-transplant time varying periodic mean tacrolimus trough level and cardiovascular event (1-year and 6-year)

Time frame: 6 year after transplantation

relationship between post-transplant time varying periodic mean tacrolimus trough level and patient mortality

the relationship between post-transplant time varying periodic mean tacrolimus trough level and patient mortality (1-year and 6-year)

Time frame: 6 year after transplantation

Central Contacts

Sangil Min

CONTACT

01071739341 surgeonmsi@gmail.com

Data from ClinicalTrials.gov

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