NCT05533008

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

December 31, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2020

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

September 8, 2022

Completed
Last Updated

September 8, 2022

Status Verified

September 1, 2022

Enrollment Period

5 months

First QC Date

November 19, 2019

Last Update Submit

September 6, 2022

Conditions

Hemodialysis

Keywords

DifelikefalinCR845Physical WithdrawalHemodialysisDialysisCKDESRD (end stage renal disease)Chronic Kidney DiseaseKidney failure, chronicKidney dysfunction

Outcome Measures

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

    Week 1-4

Secondary Outcomes (5)

  • 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

Study Arms (2)

CR845 0.5 mcg/kg

EXPERIMENTAL

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

Drug: CR845 0.5 mcg/kg

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

CR845 0.5 mcg/kgDRUG

IV CR845 0.5 mcg/kg as a bolus injection

Also known as: Difelikefalin
CR845 0.5 mcg/kg
PlaceboOTHER

IV Placebo as a bolus injection

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Cara Therapeutics Study Site

Bridgeport, Connecticut, 06606, United States

Location

Cara Therapeutics Study Site

Hartford, Connecticut, 06112, United States

Location

Cara Therapeutics Study Site

Kansas City, Kansas, 64111, United States

Location

Cara Therapeutics Study Site

Roseville, Michigan, 48066, United States

Location

Cara Therapeutics Study Site

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, Chronic

Interventions

difelikefalin

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Frédérique Menzaghi, PhD

    Cara Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2019

First Posted

September 8, 2022

Study Start

December 31, 2019

Primary Completion

June 11, 2020

Study Completion

June 11, 2020

Last Updated

September 8, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

US(5)