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Ph3, Open Label, Multi-Ctr, Pros, Rand Study -Efficacy and Safety, Conversion Prograf® Capsules BID to LCPTacro Tablets QD, for Prevent of Acute Allograft Rejection in Stable Kidney Transplant pt.

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Trial Profile

Ph3, Open Label, Multi-Ctr, Pros, Rand Study -Efficacy and Safety, Conversion Prograf® Capsules BID to LCPTacro Tablets QD, for Prevent of Acute Allograft Rejection in Stable Kidney Transplant pt.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Aug 2022

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At a glance

  • Drugs Tacrolimus (Primary)
  • 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 70052120] as well as several phase II trials.
    • 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.
    • 28 Jul 2014 According to a Veloxis Pharmaceuticals media release, marketing authorization has been granted to tacrolimus (Envarsus) based on this and another phase III trial (see profile 70052120) as well as data from an extensive Phase I and II clinical program.

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