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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: 02 Jan 2019

At a glance

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

    • 02 Jan 2019 According to a Cara Therapeutics media release, top-line data readout expected in the first half of 2019.
    • 02 Jan 2019 According to a Cara Therapeutics media release, an interim statistical analysis of the trial has been completed. Based on the recommendation of the Independent Data Monitoring Committee (IDMC), the trial will continue as planned. The IDMC's recommendation was based on the results of a prespecified interim conditional power assessment conducted after approximately 50 percent of the targeted patient number completed the designated 12-week treatment period.
    • 06 Nov 2018 According to a Cara Therapeutics media release, based on current projections, anticipates completing the planned interim assessment by year-end or early 2019 and completing the trial's 12-week treatment period by the first half of 2019.
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