Multicenter, Multi-Dose, Open-Label Maintenance of Long-Term Safety and Efficacy of Sodium Zirconium Cyclosilicate (ZS) in Hyperkalemia

Trial Profile

Multicenter, Multi-Dose, Open-Label Maintenance of Long-Term Safety and Efficacy of Sodium Zirconium Cyclosilicate (ZS) in Hyperkalemia

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Mar 2017

At a glance

  • Drugs Zirconium silicate (Primary)
  • Indications Hyperkalaemia
  • Focus Adverse reactions; Registrational
  • Sponsors ZS Pharma
  • Most Recent Events

    • 24 Feb 2017 According to an AstraZaneca media release, the Committee for Medicinal Products for Human Use (CHMP) of the EMA has issued a positive opinion recommending the approval of ZS-9 (sodium zirconium cyclosilicate) for the treatment of hyperkalaemia. The recommendation was based on data from this and three other phase III trials.
    • 05 Jan 2017 Status changed from active, no longer recruiting to completed.
    • 19 May 2016 Planned End Date changed from 1 Aug 2016 to 1 Dec 2016.
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