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A Phase 3, Randomized, Double-blind, Placebo-controlled, Phosphate Binder-combination, Parallel-group Comparative Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

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Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled, Phosphate Binder-combination, Parallel-group Comparative Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Oct 2023

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At a glance

  • Drugs Tenapanor (Primary) ; Phosphate binding modulators
  • Indications Hyperphosphataemia
  • Focus Registrational; Therapeutic Use
  • Sponsors Kyowa Kirin

    • Most Recent Events

    • 25 Sep 2023 According to a Kyowa Kirin media release, company announced that it has received an approval for manufacturing and marketing PHOZEVEL for the improvement of hyperphosphatemia in chronic kidney disease patients on dialysis based on the results of four Phase 3 clinical trials, conducted by Kyowa Kirin in Japan, in patients with hyperphosphatemia on maintenance dialysis.
    • 03 Nov 2022 According to an Ardelyx media release, data from the study were presented at the American Society of Nephrology (ASN) Kidney Week 2022.
    • 31 Oct 2022 According to an Ardelyx media release,this submission triggers an aggregate of $35 million to Ardelyx in milestone payments and payments under the recent amendment to the license agreement between Ardelyx and Kyowa Kirin.
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