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A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy in End-Stage Renal Disease (ESRD) Subjects With Hyperphosphatemia

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Tenapanor as Adjunctive Therapy to Phosphate Binder Therapy in End-Stage Renal Disease (ESRD) Subjects With Hyperphosphatemia

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 19 Oct 2023

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At a glance

  • Drugs Tenapanor (Primary) ; Calcium acetate; Calcium carbonate; Ferric citrate; Phosphate binding modulators; Sevelamer; Sucroferric oxyhydroxide
  • Indications Hyperphosphataemia
  • Focus Registrational; Therapeutic Use
  • Acronyms AMPLIFY
  • Sponsors Ardelyx

Most Recent Events

  • 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.
  • 17 May 2023 According to an Ardelyx media release, company announced that the U.S. Food and Drug Administration (FDA) has accepted its six-month review resubmission of a New Drug Application (NDA) for XPHOZAH (tenapanor) for the control of serum phosphate in adult patients with chronic kidney disease on dialysis who have had an inadequate response or intolerance to a phosphate binder therapy.

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