A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia

Trial Profile

A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Aug 2017

At a glance

  • Drugs Patiromer (Primary)
  • Indications Hyperkalaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms OPAL-HK
  • Sponsors Relypsa
  • Most Recent Events

    • 30 Aug 2017 Results (n=653) of pooled post hoc analysis assessing effect of patiromer on serum K+ in patients with HK and HF using data from AMETHYST-DN, OPAL-HK and TOURMALINE trials presented at the ESC Congress 2017: Annual Congress of the European Society of Cardiology
    • 21 Jul 2017 According to a Relypsa media release, the European Commission (EC) approved the Marketing Authorization Application (MAA) for Veltassa (patiromer) for the treatment of hyperkalemia.
    • 19 May 2017 According to a Vifor media release, based on the results from this trial, Phase 2 AMETHYST-DN trial, and from one phase 1 (CTP-700241167) trial, The Committee For Medicinal Products For Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorisation for patiromer for the treatment of hyperkalemia.
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