Clinical trial NCT06348446: Tacrolimus Exposure in Kidney Transplantation
Official title: Tacrolimus Exposure and Outcomes in Kidney Transplant Patients: A Retrospective Multicenter Study of Clinical Data Warehouse (CDW) in South Korea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Transplant Rejection
Keywords: kidney transplantation
tacrolimus
acute rejection
graft survival
adverse event
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2024-04-04
Enrollment: 12000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All renal transplant recipients between January 1, 2005 through December 31, 2014 in one of the five participating centers are included. Further selection will be undertaken to include only patients receiving oral tacrolimus as one of the main immunosuppressant at post-transplant 2 month (for early outcomes) and post-transplant 1 year (for late outcomes).

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: relationship between time varying periodic mean of tacrolimus trough and a composite 1-year allograft outcomes
timeFrame: 1 year after transplantation
Secondary outcomes:
measure: relationship between time varying periodic mean of tacrolimus trough level during 12-72 mo. post-transplant and 6-year composite allograft outcome
timeFrame: 6 year after transplantation
measure: relationship between post-transplant time varying periodic mean tacrolimus trough level and severe infection
timeFrame: 6 year after transplantation
measure: relationship between post-transplant time varying periodic mean tacrolimus trough level and cardiovascular event
timeFrame: 6 year after transplantation
measure: relationship between post-transplant time varying periodic mean tacrolimus trough level and patient mortality
timeFrame: 6 year after transplantation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center, Seoul, Korea
city: Seoul
country: Korea, Republic of
facility: Samsung medical center, Seoul, Korea
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's hospital, Seoul, Korea
city: Seoul
country: Korea, Republic of
facility: Severance hospital, Seoul, Korea
Study officials:
References: