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Prospective, Rand, Open-label, Single-center, 2 Sequence, 3 Period Crossover Study to Compare the Steady State PK of Once-Daily-Extended Release LCP-Tacro to Generic Tacrolimus Capsules Twice Daily in Stable A A Renal Transplant pt.

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Prospective, Rand, Open-label, Single-center, 2 Sequence, 3 Period Crossover Study to Compare the Steady State PK of Once-Daily-Extended Release LCP-Tacro to Generic Tacrolimus Capsules Twice Daily in Stable A A Renal Transplant pt.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Tacrolimus (Primary) ; Tacrolimus
  • Indications Renal transplant rejection
  • Focus Pharmacogenomic; Pharmacokinetics; Registrational
  • Acronyms ASERTAA
  • Sponsors Veloxis Pharmaceuticals

    • Most Recent Events

    • 28 Mar 2018 Results presented in the Veloxis Pharmaceuticals media release.
    • 28 Mar 2018 According to a Veloxis Pharmaceuticals media release, results from this trial were published in the American Journal of Kidney Diseases, Mar 2018 issue.
    • 29 Jun 2016 According to a Veloxis Pharmaceuticals media release, based on the findings from this study the company has received approval for label enhancement for the Envarsus (Tacrolimus extended-release) package insert. The FDA-approved label now contains ethnicity-specific dosing and unique genotyping guidance to Envarsus XR.

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