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

NCT02858726 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2020-07-29

Study results available
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Summary

2 Part Study: Part A will assess 3 different dosing levels of IV CR845 versus placebo in patient on hemodialysis who have moderate-to-severe itching due to uremic pruritus. Patients will receive either CR845 or placebo after each dialysis session for eight weeks. The safety and efficacy of CR845 will be monitored throughout the study. A sub-group of patients will also have pharmacokinetic assessments completed. Part B of the study will assess one dose of IVCR845 versus placebo for 12 weeks in patients on hemodialysis who have moderate-to-severe itching. The dose of CR845 used in Part B will be based on safety and efficacy found in Part A.

Conditions

  • Uremic Pruritus

Interventions

DRUG

CR845 0.5 mcg/kg

IV medication delivered three times/week

DRUG

CR845 1 mcg/kg

IV medication delivered three times/week

DRUG

CR845 1.5mcg/kg

IV medication delivered three times/week

DRUG

Placebo

IV medication delivered three times/week

Sponsors & Collaborators

  • Cara Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Frederique Menzaghi, PhD · Cara Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-03-14
Completion
2017-03-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02858726 on ClinicalTrials.gov