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The Effect of Food: An Open-Label, Randomized, Parallel Group Phase 4 Study of the Efficacy and Safety of Patiromer for Oral Suspension With or Without Food for the Treatment of Hyperkalemia (TOURMALINE)

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Trial Profile

The Effect of Food: An Open-Label, Randomized, Parallel Group Phase 4 Study of the Efficacy and Safety of Patiromer for Oral Suspension With or Without Food for the Treatment of Hyperkalemia (TOURMALINE)

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 13 Jul 2023

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At a glance

  • Drugs Patiromer (Primary)
  • Indications Hyperkalaemia
  • Focus Therapeutic Use
  • Acronyms TOURMALINE
  • Sponsors Relypsa

    • Most Recent Events

    • 01 Jul 2023 Results of post hoc pooled analysis (n=578) assessing the effect of patiromer on sP in patients with CKD, hyperkalemia, and hyperphosphatemia published in the American Journal of Kidney Diseases
    • 08 May 2018 According to the Relypsa media release, US. Food and Drug Administration has approved supplemental New Drug Application to revise the Veltassa label to reflect the data from the study. The label update is effective immediately in the US.
    • 11 Apr 2018 According to the Relypsa media release, findings from pooled analysis from this and other two trials (OPAL-HK and AMETHYST-DN) will be presented in a poster session at the National Kidney Foundation's (NKF) 2018 Spring Clinical Meetings (SCM18).
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