An observational study in Kidney Transplant Rejection, sponsored by Seoul National University Hospital. Recruiting at 4 sites in Korea, Republic of. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by Seoul National University Hospital · Observational
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.
Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
Exclusion Criteria:
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.
Time frame: 1 year after transplantation
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
Time frame: 6 year after transplantation
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)
Time frame: 6 year after transplantation
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)
Time frame: 6 year after transplantation
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)
Time frame: 6 year after transplantation
Plan to share: Undecided
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Seoul National University Hospital