Clinical Trial: Safety and Pharmacokinetics of IV CR845 in Hemodialysis Patients, and Its Efficacy in Patients With Uremic Pruritus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Pharmacokinetics of Intravenous CR845 in Hemodialysis Patients, and Its Safety and Efficacy in Hemodialysis Patients Wit

Brief Summary:

The primary purpose of this study is to:

  • Evaluate the safety and pharmacokinetic profile of repeated doses IV CR845 over one week in patients who are undergoing hemodialysis. (Part A)
  • This study is also investigating whether repeated doses of IV CR845 over two weeks is safe and effective in reducing the intensity of itching in hemodialysis patients with uremic pruritus (Part B).

Detailed Summary: Placebo-controlled
Sponsor: Cara Therapeutics, Inc.

Current Primary Outcome:

  • Part A: Determine the Pharmacokinetics of Repeated Doses of CR845 in Hemodialysis Patients (half-life, Cmax, Tmax, AUC, Vd) [ Time Frame: 1 week ]
    To evaluate the pharmacokinetics of repeated doses of CR845 in hemodialysis patients over a one-week treatment period.
  • Part B: Change in Worst Itching Intensity using a 100-mm Visual Analog Scale [ Time Frame: 2 weeks ]
    Change from baseline to the average of Week 2 worst itching (daytime and nighttime) VAS where 0 mm represents "No Itch" and 100 mm represents the "Worst Itch You Can Imagine".


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Part B: Change in quality-of-life assessed using the Skindex-10 survey [ Time Frame: 2 weeks ]
    Change from baseline to Day 15 in itch-related quality of life as assessed by the total Skindex-10 scores
  • Part B: Sleep disturbance assessed using Itch Medical Outcomes Study (MOS) survey [ Time Frame: 2 weeks ]
    Change from baseline to Day 15 in itch-related sleep disturbance based on the Itch MOS sleep problems index II (SLP-9)


Original Secondary Outcome: Same as current

Information By: Cara Therapeutics, Inc.

Dates:
Date Received: August 27, 2014
Date Started: July 2014
Date Completion:
Last Updated: August 8, 2016
Last Verified: August 2016