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A real-world evidence of the efficacy and safety of tacrolimus-based immunosuppressive regimens for lung transplant outcomes from the US Scientific Registry of Transplant Recipients (SRTR) database

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Trial Profile

A real-world evidence of the efficacy and safety of tacrolimus-based immunosuppressive regimens for lung transplant outcomes from the US Scientific Registry of Transplant Recipients (SRTR) database

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 22 Jul 2021

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At a glance

  • Drugs Azathioprine (Primary) ; Ciclosporin (Primary) ; Mycophenolate mofetil (Primary) ; Tacrolimus (Primary)
  • Indications Lung transplant rejection
  • Focus Adverse reactions; Therapeutic Use
  • Most Recent Events

    • 20 Jul 2021 According to an Astellas Pharma media release, U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for PROGRAF (tacrolimus) for the prevention of organ rejection in adult and pediatric lung transplant recipients.The sNDA submission was based on Real World Evidence (RWE) generated from a retrospective observational study of data from the U.S. Scientific Registry of Transplant Recipients (SRTR).
    • 17 May 2021 New trial record
    • 28 Apr 2021 Results presented at the 41st Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation
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