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A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

NCT03617536 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 269

Last updated 2024-01-24

Study results available
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Summary

This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of 3 dose levels of oral CR845 compared to placebo in reducing the intensity of itch in chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week Treatment Period, and a Follow-up Visit (approximately 7 days after the last dose of study drug).

Conditions

Interventions

DRUG

CR845 0.25 mg Oral Tablet

CR845 0.25 mg medication taken orally 1 time/day

DRUG

CR845 0.5 mg Oral Tablet

CR845 0.5 mg medication taken orally 1 time/day

DRUG

CR845 1 mg Oral Tablet

CR845 1 mg medication taken orally 1 time/day

DRUG

Placebo Oral Tablet

Placebo tablet taken orally 1 time/day

Sponsors & Collaborators

  • Cara Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Frédérique 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
2018-07-05
Primary Completion
2019-10-24
Completion
2019-11-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03617536 on ClinicalTrials.gov