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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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Feb 2019

At a glance

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

    • 07 Jan 2019 According to a Cara Therapeutics media release, the Company expects to report top-line data from this trial in the second half of 2019.
    • 07 Aug 2018 According to a Cara Therapeutics media release, the company will continue to focus on patient enrollment in the coming quarters and expect data readouts from both pivotal (U.S.trial-KALM 1 and this global phase 3 trial-KALM 2) trials in 2019.
    • 07 Aug 2018 According to a Cara Therapeutics media release, the company today announced the dosing of the first patient in this second pivotal study.
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