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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-31

Study Completion Date

2020-06-11

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.

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Detailed Description

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Conditions

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Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CR845 0.5 mcg/kg

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

Group Type EXPERIMENTAL

CR845 0.5 mcg/kg

Intervention Type DRUG

IV CR845 0.5 mcg/kg as a bolus injection

Placebo

IV Placebo administered after each dialysis session (3 times/week)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

IV Placebo as a bolus injection

Interventions

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CR845 0.5 mcg/kg

IV CR845 0.5 mcg/kg as a bolus injection

Intervention Type DRUG

Placebo

IV Placebo as a bolus injection

Intervention Type OTHER

Other Intervention Names

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Difelikefalin

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No