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Opioid Analgesic
Difelikefalin for Itching in Chronic Kidney Disease
Phase 3
Recruiting
Research Sponsored by Cara Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Advanced stage 4 and 5 CKD not currently on dialysis
Inadequate response to current or prior treatments (including emollients/moisturizers, topical medications, or systemic treatments) for pruritus prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12 of treatment period 1
Awards & highlights
Study Summary
This trial is studying whether the drug difelikefalin can reduce itchiness in CKD patients not on dialysis. The trial has two parts: a 12-week treatment period, and a long-term extension period of up to 52 weeks. The trial is double-blind, meaning that neither the patients nor the doctors know who is receiving the drug or the placebo.
Who is the study for?
This trial is for advanced stage 4 and 5 chronic kidney disease patients who aren't on dialysis, have had daily or near-daily itching for at least six months, and haven't found relief with current treatments. Those scheduled for a kidney transplant or dialysis during the study, or with conditions that could risk their safety or skew results, can't participate.Check my eligibility
What is being tested?
The study tests if Difelikefalin tablets can reduce itch intensity in CKD patients compared to a placebo. It's double-blind (neither doctors nor participants know who gets what), randomized (assigned by chance), includes an initial 12-week assessment phase followed by up to a year-long extension.See study design
What are the potential side effects?
While specific side effects of Difelikefalin are not listed here, common medication-related issues may include nausea, dizziness, headaches, potential allergic reactions, and gastrointestinal discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney disease is in stage 4 or 5, but I am not on dialysis.
Select...
My current or past itch treatments, including creams and pills, haven't worked.
Select...
I have had itchy skin almost every day for the last 6 months.
Select...
I have had itchy skin almost every day for the last 6 months.
Select...
My skin itchiness didn't improve with creams or lotions.
Select...
I have severe kidney disease or am on dialysis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12 of treatment period 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12 of treatment period 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy Assessment Phase (Treatment Period 1): Proportion of subjects achieving at least a 4-point improvement from baseline with respect to the weekly mean of the daily 24-hour WI-NRS score at Week 12 of Treatment Period 1
Secondary outcome measures
Efficacy Assessment Phase (Treatment Period 1): Change from baseline in Sleep Quality Questionnaire score at the end of Week 12 of Treatment Period 1.
Efficacy Assessment Phase (Treatment Period 1): Proportion of subjects achieving at least a 4-point improvement from baseline with respect to the weekly mean of the WI-NRS at Week 4 of Treatment Period 1.
Efficacy Assessment Phase (Treatment Period 1): Proportion of subjects achieving at least a 4-point improvement from baseline with respect to the weekly mean of the WI-NRS at Week 8 of Treatment Period 1.
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Difelikefalin 1 mg Oral TabletExperimental Treatment1 Intervention
Patients receive oral difelikefalin 1 mg once daily
Group II: Placebo Oral TabletPlacebo Group1 Intervention
Patients receive oral placebo once daily
Find a Location
Who is running the clinical trial?
Cara Therapeutics, Inc.Lead Sponsor
23 Previous Clinical Trials
5,378 Total Patients Enrolled
Frédérique Menzaghi, PhDStudy DirectorCara Therapeutics
9 Previous Clinical Trials
1,860 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney disease is in stage 4 or 5, but I am not on dialysis.My current or past itch treatments, including creams and pills, haven't worked.I haven't started or changed any itch treatments, including antihistamines and corticosteroids, in the last 14 days.I have had itchy skin almost every day for the last 6 months.I have had itchy skin almost every day for the last 6 months.My skin itchiness didn't improve with creams or lotions.I am scheduled for a kidney treatment like dialysis or transplant.I have severe kidney disease or am on dialysis.You have completed at least 4 pain score recordings in the past 7 days.Your average pain score before starting the study is 5 or higher on a scale from 0 to 10.
Research Study Groups:
This trial has the following groups:- Group 1: Difelikefalin 1 mg Oral Tablet
- Group 2: Placebo Oral Tablet
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some of the possible side effects of taking Difelikefalin 1 mg Oral Tablet?
"We believe that Difelikefalin 1 mg Oral Tablet is safe, as it has received a 3 on our 1-3 scale. This is a Phase 3 trial, so there is evidence of efficacy and multiple rounds of data supporting safety."
Answered by AI
Are there any availability for new participants in this trial?
"The website clinicaltrials.gov shows that this study is still open to enrolling patients. This trial was first publicized on May 17th, 2022 and was last updated on September 28th of the same year."
Answered by AI
How many human participants are allowed in this experiment?
"The sponsor, Cara Therapeutics, Inc., needs to recruit 400 eligible patients from various sites - including Cara Therapeutics Study Sites in Chattanooga, Tennessee and Cara Therapeutics Study Site 2 in Coral Gables, Florida - to fulfil the requirements of the clinical trial."
Answered by AI
Does this clinical trial have a broad reach in Canada?
"This study is running at a total of 34 sites, some of which include Chattanooga, Coral Gables and Greenville. If you enroll in the study, it would be beneficial to choose a location nearest to you in order to limit travel time and expenses."
Answered by AI
If a patient is over 35 years old, can they still enroll in this research project?
"This study includes people aged 18-85, as per the eligibility requirements."
Answered by AI
Are there any exclusionary factors for this particular trial?
"To qualify for this study, participants must suffer from pruritus and be between 18-85 years old. The trial is looking to enroll 400 individuals in total."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
Cara Therapeutics Study Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
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