Tacrolimus Exposure in Kidney Transplantation

Kidney Transplant Rejection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06348446
• Other study ID #: FY20-2963
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: March 2024
• Source: Seoul National University Hospital
• Contact: Sangil Min
• Phone: 01071739341
• Email: surgeonmsi[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12000
• Est. completion date: August 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant Rejection

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center, Seoul, Korea	Seoul
Korea, Republic of	Samsung medical center, Seoul, Korea	Seoul
Korea, Republic of	Seoul St. Mary's hospital, Seoul, Korea	Seoul
Korea, Republic of	Severance hospital, Seoul, Korea	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Astellas Pharma Inc

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year after transplantation
Secondary	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	6 year after transplantation
Secondary	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)	6 year after transplantation
Secondary	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)	6 year after transplantation
Secondary	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)	6 year after transplantation