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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hemodialysis

Intervention / Treatment
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* Drug: CR845 0.5 mcg/kg
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Difelikefalin, CR845, Physical Withdrawal, Hemodialysis, Dialysis, CKD, ESRD (end stage renal disease), Chronic Kidney Disease, Kidney failure, chronic, Kidney dysfunction