|Clinical Trial Title
|Astagraf XL to Understand the Impact of Immunosuppression on De Novo DSA Development and Chronic Immune Activation in Kidney Transplantation
|Open to Enrollment
This study will compare the incidence of a two-part composite endpoint consisting of de novo donor specific antibody (DSA) formation or a designation of "immune activation" (IA) on peripheral blood molecular profiling in patients maintained on twice daily, immediate-release tacrolimus versus those maintained on Astagraf XL in the first two years post-transplant.
Specifically, it is designed to compare the effects of twice daily, immediate-release tacrolimus and once daily Astagraf XL on DSA formation and the development of IA in de novo kidney transplant recipients during the first two years following kidney transplantation. Patients will be screened prior to surgery and randomized 1:1 to receive, within 48 hours of transplantation, immediate-release tacrolimus, administered twice daily, or Astagraf XL, as a component of a standard immunosuppression maintenance regimen also consisting of corticosteroids (if given per institutional protocol) and mycophenolate mofetil (MMF) (or Myfortic® equivalent).