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?

An 8-week, Multicenter, Randomized, Double-Blind, Parallel Group Study With a 4-week, Placebo-Controlled, Randomized Withdrawal Period to Evaluate the Efficacy, Safety, and Tolerability of Tenapanor to Treat Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)

Trial Profile

An 8-week, Multicenter, Randomized, Double-Blind, Parallel Group Study With a 4-week, Placebo-Controlled, Randomized Withdrawal Period to Evaluate the Efficacy, Safety, and Tolerability of Tenapanor to Treat Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Oct 2023

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 Tenapanor (Primary)
  • Indications Hyperphosphataemia
  • Focus Registrational; Therapeutic Use
  • Acronyms BLOCK
  • 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.
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
Back to top