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Opioid Receptor Agonist
A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
Phase 2
Waitlist Available
Research Sponsored by Cara Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12
Awards & highlights
All Individual Drugs Already Approved
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).
Eligible Conditions
- Itching
- Local Itching at Injection Site
- Chronic Kidney Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score During Week 12
Secondary study objectives
Change From Baseline in 5-D Itch Scale Score at the End of Week 12
Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: CR845 1 mg Oral TabletExperimental Treatment1 Intervention
Oral CR845 1 mg to be taken orally once daily for 12 weeks
Group II: CR845 0.5 mg Oral TabletExperimental Treatment1 Intervention
Oral CR845 0.5 mg to be taken orally once daily for 12 weeks
Group III: CR845 0.25 mg Oral TabletExperimental Treatment1 Intervention
Oral CR845 0.25 mg to be taken orally once daily for 12 weeks
Group IV: Placebo Oral TabletPlacebo Group1 Intervention
Oral Placebo to be taken orally once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Difelikefalin
FDA approved
Difelikefalin
FDA approved
Difelikefalin
FDA approved
Find a Location
Who is running the clinical trial?
Cara Therapeutics, Inc.Lead Sponsor
23 Previous Clinical Trials
4,874 Total Patients Enrolled
Frédérique Menzaghi, PhDStudy DirectorCara Therapeutics
9 Previous Clinical Trials
1,582 Total Patients Enrolled