Tacrolimus Exposure in Kidney Transplantation

Recruiting

• Conditions: Kidney Transplant Rejection

• Registration Number: NCT06348446
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-24
• Study First Submitted QC: 2024-03-31
• Last Update Submitted: 2024-03-31
• Study First Posted: 2024-04-04
• Last Update Posted: 2024-04-04
• Primary Completion: 2024-07-30
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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)

Trial Locations

Locations (4)

Samsung medical center, Seoul, Korea; 🇰🇷 Seoul, Korea, Republic of

Severance hospital, Seoul, Korea; 🇰🇷 Seoul, Korea, Republic of

Asan medical center, Seoul, Korea; 🇰🇷 Seoul, Korea, Republic of

Seoul St. Mary's hospital, Seoul, Korea; 🇰🇷 Seoul, Korea, Republic of