CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients

This is a multicenter, randomized, double-blind, placebo-controlled study to assess the potential of physical withdrawal from CR845 upon treatment discontinuation after 3 weeks of IV administration at a dose of 0.5 mcg/kg in hemodialysis patients. The purpose of this study is to determine whether hemodialysis patients who take CR845 develop physical dependence and experience withdrawal symptoms upon cessation, as exemplified by symptoms consistent with opioid withdrawal. The study will consist of a Screening Phase, a 3-week Open-label Phase, a 2-week randomized, placebo-controlled, Double-blind Phase and a Follow-up Visit.

Study Overview

• Status: Completed
• Conditions: Hemodialysis
• Intervention / Treatment: Drug: CR845 0.5 mcg/kg; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • Cara Therapeutics Study Site
    • Hartford, Connecticut, United States, 06112
      • Cara Therapeutics Study Site
  • Kansas
    • Kansas City, Kansas, United States, 64111
      • Cara Therapeutics Study Site
  • Michigan
    • Roseville, Michigan, United States, 48066
      • Cara Therapeutics Study Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Cara Therapeutics Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Has ESRD and has been on hemodialysis 3 times per week for at least 3 months;
• Not currently taking opioid medication;
• If female, is not pregnant or nursing during any period of the study.

Key Exclusion Criteria:

• Has a concomitant disease or a history of any condition that, in the opinion of the Investigator, could pose undue risk to the patient, impede completion of the study procedures, or would compromise the validity of the study measurements; Past or present diseases, which as judged by the Investigator, may affect the outcome of this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CR845 0.5 mcg/kg; IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)	Drug: CR845 0.5 mcg/kg; IV CR845 0.5 mcg/kg as a bolus injection; Other Names: Difelikefalin
Placebo Comparator: Placebo; IV Placebo administered after each dialysis session (3 times/week)	Other: Placebo; IV Placebo as a bolus injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Treatment difference between placebo and CR845-treated group with respect to the maximum Clinical Opiate Withdrawal Scale (COWS) score over Weeks 1-4	Week 1-4

Secondary Outcome Measures

Outcome Measure	Time Frame
Treatment difference between placebo and CR845-treated group for COWS score at Week 4.	Week 4
Treatment difference between placebo and CR845-treated group for COWS score at Week 5.	Week 5
Treatment difference between placebo and CR845-treated group for maximum Subjective Opiate Withdrawal Scale (SOWS) score over Weeks 1-4	Week 1-4
Treatment difference between placebo and CR845-treated group for SOWS score at Week 4.	Week 4
Treatment difference between placebo and CR845-treated group for SOWS score at Week 5.	Week 5

Collaborators and Investigators

• Sponsor: Cara Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2019
• Primary Completion (Actual): June 11, 2020
• Study Completion (Actual): June 11, 2020

Study Registration Dates

• First Submitted: November 19, 2019
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; CKD; Dialysis; Hemodialysis; Difelikefalin; CR845; Physical Withdrawal; ESRD (end stage renal disease); Kidney failure, chronic; Kidney dysfunction
• Other Study ID Numbers: CR845-100303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No