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A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Etelcalcetide (Primary)
  • Indications Secondary hyperparathyroidism
  • Focus Registrational; Therapeutic Use
  • Sponsors Amgen; KAI Pharmaceuticals

    • Most Recent Events

    • 30 Jul 2020 Results of meta-analysis of four studies (NCT01785849, NCT01254565, JapicCTI142664 & JapicCTI121978) assessing efficacy and safety of etelcalcetide for the treatment of secondary hyperparathyroidism (SHPT) in patients receiving hemodialysis, published in the Clinical Nephrology.
    • 15 Feb 2017 According to an Ono Pharmaceuticals media release, in the US, Amgen received an approval for a New Drug Application (NDA) of Parsabiv for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis from the Food and Drug Administration (FDA) on February 7, 2017.
    • 07 Feb 2017 According to an Amgen media release, the US FDA has appoved etelcalcetide (Parsabiv) fo the treatment of secondary hyperthyroidism in adult patients on hemodialysis. The approval was based on data from this and another phase III trial (CTP 700239772).

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