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A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus, With a 52-Week Open Label Extension

Trial Profile

A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus, With a 52-Week Open Label Extension

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Nov 2019

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At a glance

  • Drugs Difelikefalin (Primary)
  • Indications Pruritus
  • Focus Registrational; Therapeutic Use
  • Acronyms KALM-2
  • Sponsors Cara Therapeutics
  • Most Recent Events

    • 17 Oct 2019 Planned primary completion date changed from 1 Dec 2019 to 1 Mar 2020.
    • 14 Oct 2019 According to a Cara Therapeutics media release, the company has randomized more than 350 patients in the trial, till date. The company expects the trial to be fully enrolled by the end of this quarter and remain on track to file our New Drug Application (NDA) for KORSUVA Injection for the treatment of moderate-to-severe CKD-aP in hemodialysis patients in the second half of 2020.
    • 14 Oct 2019 Status changed from active, no longer recruiting to recruiting, according to a Cara Therapeutics media release.
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