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A Phase 3 randomized, single-blind, parallel two-arm, placebo-controlled, multicenter, study of the efficacy and safety of Triferic® administered via hemodialysate in maintaining iron delivery and hemoglobin concentration in anemic adult patients with chronic kidney disease requiring hemodialysis

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Trial Profile

A Phase 3 randomized, single-blind, parallel two-arm, placebo-controlled, multicenter, study of the efficacy and safety of Triferic® administered via hemodialysate in maintaining iron delivery and hemoglobin concentration in anemic adult patients with chronic kidney disease requiring hemodialysis

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Apr 2022

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At a glance

  • Drugs Ferric pyrophosphate (Primary)
  • Indications Iron deficiency anaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Wanbang Biopharma

    • Most Recent Events

    • 25 Apr 2022 According to a Rockwell Medical media release, the study was discussed with regulators from the Center for Drug Evaluation (CDE), part of the NMPA, at a very early stage, and was designed with feedback from those initial meetings.
    • 25 Apr 2022 According to a Rockwell Medical media release, Wanbang Biopharmaceuticals enrolled the final patient, ahead of schedule in this trial. The company plans to submit a New Drug Approval (NDA) submission to China's National Medical Products Administration (NMPA) in the third quarter of 2023. This trial is expected to complete by 2023.
    • 25 Apr 2022 Status changed from recruiting to active, no longer recruiting, according to a Rockwell Medical media release.

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