Tacrolimus Exposure in Kidney Transplantation

Tacrolimus Exposure and Outcomes in Kidney Transplant Patients: A Retrospective Multicenter Study of Clinical Data Warehouse (CDW) in South Korea

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06348446

Enrollment

12000

Registered

2024-04-04

Start date

2022-02-01

Completion date

2024-08-30

Last updated

2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant Rejection

Keywords

kidney transplantation, tacrolimus, acute rejection, graft survival, adverse event

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
relationship between time varying periodic mean of tacrolimus trough and a composite 1-year allograft outcomes	1 year after transplantation	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.

Secondary

Measure	Time frame	Description
relationship between time varying periodic mean of tacrolimus trough level during 12-72 mo. post-transplant and 6-year composite allograft outcome	6 year after transplantation	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
relationship between post-transplant time varying periodic mean tacrolimus trough level and severe infection	6 year after transplantation	the relationship between post-transplant time varying periodic mean tacrolimus trough level and severe infection (1-year and 6-year)
relationship between post-transplant time varying periodic mean tacrolimus trough level and cardiovascular event	6 year after transplantation	the relationship between post-transplant time varying periodic mean tacrolimus trough level and cardiovascular event (1-year and 6-year)
relationship between post-transplant time varying periodic mean tacrolimus trough level and patient mortality	6 year after transplantation	the relationship between post-transplant time varying periodic mean tacrolimus trough level and patient mortality (1-year and 6-year)

Countries

South Korea

Contacts

Primary ContactSangil Min

surgeonmsi@gmail.com01071739341

Outcome results