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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

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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: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Nov 2023

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At a glance

  • Drugs Difelikefalin (Primary)
  • Indications Pruritus
  • Focus Registrational; Therapeutic Use
  • Acronyms KALM-1
  • Sponsors Cara Therapeutics
  • Most Recent Events

    • 15 Nov 2023 Results of pooled dataset from KALM-1 and KALM-2 and NCT03998163 , evaluating whether itch reduction in CKD-aP improved sleep quality, published in the Nephrology Dialysis Transplantation
    • 18 May 2023 According to Vifor Pharma media release, based on the data from KALM-1, KALM-2 as well as supportive data from an additional 32 clinical studies, England National Institute for Health and Care Excellence (NICE) has recommended Kapruvia for the treatment of moderate-to-severe CKD-associated pruritus in adult patients on haemodialysis.
    • 19 Aug 2022 According to a Cara Therapeutics media release, based on the data from KALM-1, KALM-2 as well as supportive data from an additional 32 clinical studies, the company received approval for Kapruvia from the Swiss Agency for Therapeutic Products (Swissmedic).
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