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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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Trial Profile

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: 21 May 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

    • 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.
    • 17 May 2023 According to an Ardelyx media release, The FDA has set a user fee goal date of October 17, 2023 and the company expects XPHOZAH to be commercially available in the fourth quarter of 2023, following an approval from the FDA.

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