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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Zirconium silicate (Primary)
  • Indications Hyperkalaemia
  • Focus Registrational; Therapeutic Use
  • Sponsors ZS Pharma

    • Most Recent Events

    • 06 Feb 2020 Results of post hoc analysis comparing SZC efficacy and safety >12months among outpatients with hyperkalaemia and Stages 4 and 5 chronic kidney disease (CKD) versus those with Stages 1-3 CKD, published in the Nephrology Dialysis Transplantation
    • 18 May 2018 According to an AstraZaneca media release, based on the data of these studies (238578, 240595,240601, 242292 and 242482), the US Food and Drug Administration (FDA) has approved LOKELMATM (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of hyperkalemia in adults.
    • 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.

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