Phase II/III, open-label, randomized, controlled, multiple-dose study of efficacy and safety of BMS-224818 as part of a quadruple drug regimen in first renal transplant recipients.

Trial Profile

Phase II/III, open-label, randomized, controlled, multiple-dose study of efficacy and safety of BMS-224818 as part of a quadruple drug regimen in first renal transplant recipients.

Completed
Phase of Trial: Phase II

Latest Information Update: 31 Jul 2017

At a glance

  • Drugs Belatacept (Primary) ; Ciclosporin
  • Indications Renal transplant rejection
  • Focus Registrational; Therapeutic Use
  • Sponsors Bristol-Myers Squibb
  • Most Recent Events

    • 31 Jul 2017 Results of intent-to-treat post hoc analysis over ten years published in the American Journal of Transplantation
    • 10 Jun 2017 Biomarkers information updated
    • 03 Mar 2010 The US FDA's Cardiovascular and Renal Drugs Advisory Committee recommended approval of belatacept following a review of belatacept clinical development programme which included data from this trial, according to a Bristol-Myers Squibb media release.
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