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

Cara Therapeutics

Status and phase

Completed

Phase 1

Conditions

Hemodialysis

Treatments

Drug: CR845 0.5 mcg/kg

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05533008

CR845-100303

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.