Tacrolimus Exposure in Kidney Transplantation

NCT06348446 | Recruiting

• 1 other identifier: FY20-2963
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 4

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.

Conditions

Kidney Transplant Rejection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

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

  6 year after transplantation

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

  6 year after transplantation

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

  6 year after transplantation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Astellas Pharma Inc: collaborator

Study Sites (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

Severance hospital, Seoul, Korea

Seoul, South Korea

RECRUITING

Central Study Contacts

Sangil Min

CONTACT

01071739341; surgeonmsi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 4, 2024
• Study Start: February 1, 2022
• Primary Completion: July 30, 2024
• Study Completion: August 30, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-03

Locations

KR (4)