Ph3,DB/DD,Multi-Ctr,Pros,Rand Study-Efficacy and Safety of LCP-Tacro Tablets, QD, Compared to Prograf Capsules,BID, in Combination With Mycophenolate Mofetil for Acute Allograft Rejection in De Novo Kidney Transplant.

Trial Profile

Ph3,DB/DD,Multi-Ctr,Pros,Rand Study-Efficacy and Safety of LCP-Tacro Tablets, QD, Compared to Prograf Capsules,BID, in Combination With Mycophenolate Mofetil for Acute Allograft Rejection in De Novo Kidney Transplant.

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Sep 2016

At a glance

  • Drugs Tacrolimus (Primary) ; Tacrolimus
  • Indications Renal transplant rejection
  • Focus Registrational; Therapeutic Use
  • Sponsors Veloxis Pharmaceuticals
  • Most Recent Events

    • 10 Jul 2015 According to a Veloxis Pharmaceuticals media release, Envarsus XR [tacrolimus extended-release] has been approved by the U.S. FDA for the prevention of kidney transplant rejection in patients who require conversion from other twice-daily tacrolimus products to once-daily Envarsus XR. The approval is based on the review from this and another phase III trial [see CT profile 7004027] as well as several phase II trials.
    • 04 May 2015 Results presented at the American Transplant Congress 2015, according to a Veloxis Pharmaceuticals media release.
    • 03 Mar 2015 According to a Veloxis Pharmaceuticals media release, the FDA has accepted for standard review the company's NDA for Envarsus for the prevention of organ rejection in adult kidney transplant patients.
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