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Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

NCT03281538 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2021-10-14

Study results available
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Summary

This is an open-label multicenter, long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks.

Conditions

  • Uremic Pruritus

Interventions

DRUG

CR845

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

Sponsors & Collaborators

  • Cara Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Frederique Menzaghi · Cara Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-14
Primary Completion
2020-02-11
Completion
2020-02-11
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

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 NCT03281538 on ClinicalTrials.gov