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CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

NCT03998163 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2021-10-15

Study results available
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Summary

This is a multicenter, open-label study to evaluate the safety and effectiveness of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes an up to 12-week Treatment Period.

Conditions

  • Uremic Pruritus

Interventions

DRUG

CR845 0.5 mcg/kg

IV CR845 0.5 mcg/kg administered three times/week

Sponsors & Collaborators

  • Cara Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Frédérique Menzaghi, PhD · Cara Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-06
Primary Completion
2020-02-26
Completion
2020-03-06
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Hungary
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03998163 on ClinicalTrials.gov