Multicenter, Prospective, Randomized, Placebo-Controlled, Double-blind Dose Escalating Study of Safety, Tolerability and Pharmacodynamics of Zirconium Silicate in Chronic Kidney Disease and Moderate Kidney Dysfunction With Mild Hyperkalemia

Trial Profile

Multicenter, Prospective, Randomized, Placebo-Controlled, Double-blind Dose Escalating Study of Safety, Tolerability and Pharmacodynamics of Zirconium Silicate in Chronic Kidney Disease and Moderate Kidney Dysfunction With Mild Hyperkalemia

Completed
Phase of Trial: Phase II

Latest Information Update: 24 Feb 2017

At a glance

  • Drugs Zirconium silicate (Primary)
  • Indications Hyperkalaemia
  • Focus Proof of concept; Therapeutic Use
  • 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.
    • 15 Apr 2015 According to ZS Pharma Media Release, the data from this trial was published in Kidney International Feb 2015.
    • 15 Apr 2015 Primary endpoint (Potassium levels (Change in serum potassium levels from baseline during the first 48h) has been met, according to ZS Pharma Media Release.
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