A multicenter, four arm, randomized, open label clinical study investigating optimized dosing in a Prograf/Advagraf-based immunosuppressive regimen in kidney transplant subjects.

Trial Profile

A multicenter, four arm, randomized, open label clinical study investigating optimized dosing in a Prograf/Advagraf-based immunosuppressive regimen in kidney transplant subjects.

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Nov 2017

At a glance

  • Drugs Tacrolimus (Primary) ; Basiliximab; Corticosteroids; Mycophenolate mofetil
  • Indications Renal transplant rejection
  • Focus Therapeutic Use
  • Acronyms OSAKA
  • Sponsors Astellas Pharma
  • Most Recent Events

    • 01 Nov 2017 Results of pooled analysis of NCT00189839 and NCT00717470 trials comparing outcomes with prolonged-release tacrolimus and immediate-release tacrolimus published in the Transplantation Proceedings
    • 12 Jul 2014 EudraCT reports trial as recruiting in France, Spain, United Kingdom and Slovakia and completed in remaining countries; status retained as per NCT as it is recently updated..
    • 11 Sep 2013 Results assessing outcomes in recipients of extended-criteria donor kidneys versus standard-criteria donor kidneys presented at the 16th Congress of the European Society for Organ Transplantation.
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