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A 26-Wk, Phase 3, Open Label (OL) Study With a 12-Wk, Placebo-Controlled, Randomized Withdrawal Period and an OL Safety Extension to Evaluate the Safety and Efficacy of Tenapanor to Treat Hyperphosphatemia in CKD Patients on Dialysis

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A 26-Wk, Phase 3, Open Label (OL) Study With a 12-Wk, Placebo-Controlled, Randomized Withdrawal Period and an OL Safety Extension to Evaluate the Safety and Efficacy of Tenapanor to Treat Hyperphosphatemia in CKD Patients on Dialysis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Oct 2024

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At a glance

  • Drugs Tenapanor (Primary) ; Sevelamer
  • Indications Hyperphosphataemia
  • Focus Registrational; Therapeutic Use
  • Acronyms Phreedom
  • Sponsors Ardelyx

    • Most Recent Events

    • 15 Oct 2024 According to an Ardelyx media release, additional data supporting XPHOZAH (tenapanor) from this trial will be presented at the American Society of Nephrologys (ASN) Kidney Week, to be held October 24-27, 2024, in San Diego.
    • 16 May 2024 According to an Ardelyx media release, clinical data from this trial was presented in a series of poster presentations at the National Kidney Foundation (NKF) 2024 Spring Clinical Meetings, now underway in Long Beach, California.
    • 17 Oct 2023 According to an Ardelyx media release, company announced that the U.S. Food and Drug Administration (FDA) has approved XPHOZAH, based on three Phase 3 clinical trials PHREEDOM, BLOCK and AMPLIFY.

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