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Equivalence of Triferic (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients

Trial Profile

Equivalence of Triferic (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 06 Aug 2019

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At a glance

  • Drugs Ferric pyrophosphate (Primary) ; Ferric pyrophosphate (Primary)
  • Indications Iron metabolism disorders
  • Focus Pharmacokinetics; Registrational
  • Sponsors Rockwell Medical Technologies
  • Most Recent Events

    • 06 Aug 2019 According to a Rockwell Medical Technologies media release, based on the results of this study, the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for its Intravenous (I.V.) formulation of TRIFERIC with a PDUFA (Prescription Drug User Fee Act) date of March 28, 2020.
    • 29 May 2019 According to a Rockwell Medical Technologies media release, based on the results of this study, the company has completed the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the Intravenous (I.V.) formulation of Triferic (Ferric pyrophosphate citrate).
    • 09 May 2019 According to a Rockwell Medical Technologies media release, data from this trial was presented at the 39th Annual Dialysis Conference in March 2019.
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