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A Long-Term, Open Label Study to Evaluate the Ability of Tenapanor Alone or in Combination With Sevelamer to Treat to Goal Serum Phosphorus in Patients With End-Stage Kidney Disease on Dialysis (NORMALIZE)

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Trial Profile

A Long-Term, Open Label Study to Evaluate the Ability of Tenapanor Alone or in Combination With Sevelamer to Treat to Goal Serum Phosphorus in Patients With End-Stage Kidney Disease on Dialysis (NORMALIZE)

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 05 Aug 2024

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At a glance

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

    • Most Recent Events

    • 31 Jul 2024 According to an Ardelyx media release, plain language summaries of results from this study were presented in Current Medical Research and Opinion.
    • 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 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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