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

NCTNCT05533008Other idCR845-100303

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Overview

Status: Completed
Phase: Phase 1
Enrollment: 35 participants (actual)
Sponsor: Cara Therapeutics, Inc. · Industry
Design: Randomized · Double masking
Countries: 1 country
United States
Start: 31 Dec 2019
Primary completion: 11 Jun 2020
Completion: 11 Jun 2020
First posted: 8 Sept 2022
Last update posted: 8 Sept 2022
Conditions: Hemodialysis

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201920202021

Ph 1
CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients
NCT05533008
31 Dec 2019 to 11 Jun 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

CR845 0.5 mcg/kgDrug
PlaceboOther

Arms2

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

Primary outcomes1

Outcomes the sponsor listed as primary.

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

Secondary outcomes(5)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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