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
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
- 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.