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A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

Trial Profile

A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 01 Nov 2019

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At a glance

  • Drugs Difelikefalin (Primary)
  • Indications Pruritus
  • Focus Therapeutic Use
  • Sponsors Cara Therapeutics
  • Most Recent Events

    • 01 Nov 2019 According to a Cara Therapeutics media release, data from this study will be presented at the upcoming at Kidney Week 2019, the American Society of Nephrologys Annual Meeting, to be held November 5-10, 2019, in Washington, DC.
    • 22 Jul 2019 According to an Cara Therapeutics Media release, based on the recommendation of the Independent Data Monitoring Committee (IDMC), the trial does not require any modifications to the original enrollment target which is based on the results of a prespecified interim conditional power assessment conducted after approximately 50% of the 240 patients had completed the designated 12-week treatment period.
    • 22 Jul 2019 According to an Cara Therapeutics Media release, the company announced the completion of an interim statistical assessment of this study with full enrollment of 240 patients. Top-line data is expected in the fourth quarter of 2019.
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