Clinical trial NCT05533008: CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hemodialysis
Keywords: Difelikefalin
CR845
Physical Withdrawal
Hemodialysis
Dialysis
CKD
ESRD (end stage renal disease)
Chronic Kidney Disease
Kidney failure, chronic
Kidney dysfunction
Lead sponsor: Cara Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment difference between placebo and CR845-treated group with respect to the maximum Clinical Opiate Withdrawal Scale (COWS) score over Weeks 1-4
timeFrame: Week 1-4
Secondary outcomes:
measure: Treatment difference between placebo and CR845-treated group for COWS score at Week 4.
timeFrame: Week 4
measure: Treatment difference between placebo and CR845-treated group for COWS score at Week 5.
timeFrame: Week 5
measure: Treatment difference between placebo and CR845-treated group for maximum Subjective Opiate Withdrawal Scale (SOWS) score over Weeks 1-4
timeFrame: Week 1-4
measure: Treatment difference between placebo and CR845-treated group for SOWS score at Week 4.
timeFrame: Week 4
measure: Treatment difference between placebo and CR845-treated group for SOWS score at Week 5.
timeFrame: Week 5
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: Cara Therapeutics Study Site
state: Connecticut
city: Hartford
country: United States
facility: Cara Therapeutics Study Site
state: Connecticut
city: Kansas City
country: United States
facility: Cara Therapeutics Study Site
state: Kansas
city: Roseville
country: United States
facility: Cara Therapeutics Study Site
state: Michigan
city: Minneapolis
country: United States
facility: Cara Therapeutics Study Site
state: Minnesota
Study officials:
affiliation: Cara Therapeutics
name: Frédérique Menzaghi, PhD
role: STUDY_DIRECTOR
References: