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

Phase 1

Completed

• Conditions: Hemodialysis
• Interventions: Drug: CR845 0.5 mcg/kg; Other: Placebo

• Registration Number: NCT05533008
• Lead Sponsor: Cara Therapeutics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-19
• Study Start: 2019-12-31
• Primary Completion: 2020-06-11
• Study Completion: 2020-06-11
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-06
• Last Update Submitted: 2022-09-06
• Study First Posted: 2022-09-08
• Last Update Posted: 2022-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CR845 0.5 mcg/kg	CR845 0.5 mcg/kg	IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
Placebo	Placebo	IV Placebo administered after each dialysis session (3 times/week)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 SOWS score at Week 4.	Week 4
Treatment difference between placebo and CR845-treated group for SOWS 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

Trial Locations

Locations (1)

Cara Therapeutics Study Site; 🇺🇸 Minneapolis, Minnesota, United States