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NCT Number: NCT05533008

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

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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Key information

Conditions

Hemodialysis Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cara Therapeutics Study Site, Bridgeport, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CR845 0.5 mcg/kg

Drug

IV CR845 0.5 mcg/kg as a bolus injection

Other names: Difelikefalin

Placebo

Other

IV Placebo as a bolus injection

Primary outcomes

  1. 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

  1. Treatment difference between placebo and CR845-treated group for COWS score at Week 4.

    Time frame: Week 4

  2. Treatment difference between placebo and CR845-treated group for COWS score at Week 5.

    Time frame: Week 5

  3. 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

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

    Time frame: Week 4

  5. Treatment difference between placebo and CR845-treated group for SOWS score at Week 5.

    Time frame: Week 5

Sponsors and collaborators

Lead sponsor

Cara Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 8, 2022
Registry last updated
Sep 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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