Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
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

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

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

    • 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.
    • 08 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 700237973).
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Legal
Back to top