Multicenter, Multi-phase, Multi-dose, Prospective, Double-blind, Placebo-controlled, Maintenance Study of Safety and Efficacy of ZS (Microporous, Fractionated, Protonated Zirconium Silicate) in Hyperkalemia.

Trial Profile

Multicenter, Multi-phase, Multi-dose, Prospective, Double-blind, Placebo-controlled, Maintenance Study of Safety and Efficacy of ZS (Microporous, Fractionated, Protonated Zirconium Silicate) in Hyperkalemia.

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Feb 2017

At a glance

  • Drugs Zirconium silicate (Primary)
  • Indications Hyperkalaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms HARMONIZE
  • 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.
    • 16 Nov 2016 Results of post-hoc pooled analysis (n=153) of data from two phase III ZS-9 trials (ZS-003 and HARMONIZE) assessing the effects of ZS-9 in heart failure patients with hyperkalemia on maximal doses of RAASi, submaximal RAASi, or no RAASi at baseline, presented at the 89th Annual Scientific Sessions of the American Heart Association.
    • 04 Feb 2016 According to an AstraZeneca media release, the regulatory submissions for zirconium silicate [ZS 9] in the treatment of hyperkalaemia have been accepted for review by the CHMP of EMA and the US FDA.
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