Clinical Trial: Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Two-Part, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe This is a two-part study. Patients participating in Part A will be consented and trained on the completion of questionnaires about the severity of itching and overall health. Patients will be required to complete questionnaires during their visits to the dialysis center and also while at home on other days. Results of the screening questionnaires will assess eligibility for the study. Additional laboratory tests and measurements for safety will also be completed during the screening period. Patients meeting all criteria for entry into Part A of the study will be randomized to receive either one of three different doses of CR845 or a placebo. Patients will receive the study drug for eight weeks IV after each hemodialysis treatment (i.e. 3 times per week). Assessments for intensity of itch and safety will also be completed during the 8 week treatment period. When patients have completed treatment, a Follow-up visit will be completed 7 days later.

Patients participating in Part B will be consented and trained on the completion of questionnaires about itching and overall health. Patients will be required to complete questionnaires during their visits to the dialysis center and also while at home on other days. Laboratory tests and measurements for safety will also be completed during the screening period to determine study eligibility. Patients meeting all criteria for entry into Part B of the study will be randomized to receive either CR845 or a placebo. The dose of CR845 used will have been determined based on the safety and efficacy from Part A. Patients will be dosed with either CR845 or placebo for twelve weeks after each hemodialysis treatment (i.e. 3 times per week). Assessments for intensity of itch and safety will be completed during the treatment period also. When patients have completed treatment, a Follow-up visit will be completed 7 days later.

Current Primary Outcome:

• Part A: An assessment of 3 dose levels of CR845 and placebo in reducing the intensity of itch in hemodialysis patients [ Time Frame: 8 weeks ]
  Patient reported intensity of itch using the Worst Itching Intensity Numerical Rating Scale
• Part B: An assessment of CR845 compared to placebo in reducing the intensity of itch in hemodialysis patients [ Time Frame: 12 weeks ]
  Patient reported intensity of itch using the Worst Itching Intensity Numerical Rating Scale

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Part A and Part B: Safety of IV CR845 will be assessed by physical examination, monitoring of adverse events, vital signs and laboratory assessments [ Time Frame: up to 12 weeks ]
  The safety of CR845 will be assessed in this patient population by physical examination, monitoring of adverse events, vital signs and laboratory assessments at specified times. Participants with clinically significant laboratory values or abnormal exam findings, as well as those with adverse events related to study drug,will be compared to those receiving placebo.
• Part A: The pharmacokinetic profile of CR845 will be determined between Week 1 and Week 8. The calculation of the accumulation ratio between the first and last doses with respect to Cmax will be reported. [ Time Frame: 8 weeks ]
  To evaluate the pharmacokinetics of 3 dose levels of CR845 given 3 times a week for 8 weeks.
• Part A: The pharmacokinetic profile of CR845 will be determined between Week 1 and Week 8. The calculation of the accumulation ratio between the first and last doses with respect to AUC will be reported. [ Time Frame: 8 weeks ]
  To evaluate the pharmacokinetics of 3 dose levels of CR845 given 3 times a week for 8 weeks.

Original Secondary Outcome: Same as current

Information By: Cara Therapeutics, Inc.

Dates:
Date Received: July 29, 2016
Date Started: June 2016
Date Completion: February 2018
Last Updated: December 16, 2016
Last Verified: December 2016