A Randomized, Double-Blinded, Placebo-Controlled, Crossover, Multicenter Phase III Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in Chronic Kidney Disease Patients Receiving Chronic Hemodialysis

Trial Profile

A Randomized, Double-Blinded, Placebo-Controlled, Crossover, Multicenter Phase III Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in Chronic Kidney Disease Patients Receiving Chronic Hemodialysis

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Oct 2016

At a glance

  • Drugs Ferric pyrophosphate (Primary)
  • Indications Iron deficiency anaemia
  • Focus Adverse reactions; Registrational
  • Sponsors Rockwell Medical Technologies
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 26 Feb 2015 According to a Rockwell Medical media release, company received U.S. FDA market approval for Triferic for iron replacement and maintenance of hemoglobin in hemodialysis patients.
    • 06 Nov 2014 The Oncologic Drugs Advisory Committee of the US FDA recommended that the Phase III Triferic efficacy and safety results support a positive benefit/risk, according to a Rockwell Medical media release.
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