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Multicenter, Two-phase, Multi-dose, Prospective, Randomized, Double-blind, Placebo-Controlled Study of Safety and Efficacy of Microporous, Fractionated, Protonated Zirconium Silicate in Mild to Moderate Hyperkalemia

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Trial Profile

Multicenter, Two-phase, Multi-dose, Prospective, Randomized, Double-blind, Placebo-Controlled Study of Safety and Efficacy of Microporous, Fractionated, Protonated Zirconium Silicate in Mild to Moderate Hyperkalemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Jul 2020

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At a glance

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

Most Recent Events

  • 26 Jun 2020 Results (n=1278) of post-hoc analysis assessing serum bicarbonate and urea, and urine pH data from three trials (ZS-003, NCT01737697; HARMONIZE, NCT02088073; and HARMONIZE-Global), 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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