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Randomized, Open Label, Multicenter Study of Belatacept-based Early Steroid Withdrawal Regimen With Alemtuzumab or rATG Induction Compared to Tacrolimus-based Early Steroid Withdrawal Regimen With rATG Induction in Renal Transplantation

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Trial Profile

Randomized, Open Label, Multicenter Study of Belatacept-based Early Steroid Withdrawal Regimen With Alemtuzumab or rATG Induction Compared to Tacrolimus-based Early Steroid Withdrawal Regimen With rATG Induction in Renal Transplantation

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 16 Feb 2022

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At a glance

  • Drugs Belatacept (Primary) ; Alemtuzumab; Antithymocyte globulin; Antithymocyte globulin; Glucocorticoids; Methylprednisolone; Mycophenolate mofetil; Mycophenolate sodium; Prednisone; Steroids; Tacrolimus
  • Indications Renal transplant rejection
  • Focus Therapeutic Use
  • Acronyms BEST

    • Most Recent Events

    • 09 Jun 2021 Results (n=191) assessing pharmacokinetic parameters were analyzed with clinical data of any infection, severe bacterial, fungal, or viral from BEST trial samples, presented at the 2021 American Transplant Congress.
    • 09 Jun 2021 Results (n=191) assessing pharmacokinetic parameters and Cavg at time of acute rejection were analyzed for acute rejection and recurrent acute rejection from BELA-based Early Steroid-withdrawal Trial (BEST) trials, presented at the 2021 American Transplant Congress.
    • 09 Jun 2021 Results (n=316) assessing clinically relevant pre- and post-transplant outcomes [chronic dialysis versus pre-emptive, acute rejection, diabetes (preexisting, new onset diabetes after transplant (NODAT), death, death censored graft loss (DCGL), and eGFR less than 45] predicted worse PROs over two years, presented at the 2021 American Transplant Congress.
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