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Opioid Analgesic
Difelikefalin for Itching in Chronic Kidney Disease
Verified Trial
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
Subject self-reports experiencing daily or near-daily pruritus for at least 6 months prior to screening.
Inadequate response to current or prior topical treatments (including emollients) for pruritus prior to screening.
Must not have
New or change of treatment received for itch, including antihistamines and corticosteroids (oral, intravenous, or topical), within 14 days prior to screening.
Timeline
Screening 4 weeks
Treatment 12 weeks
Follow Up 1 weeks
Awards & highlights
Study Summary
This trial is testing a drug to see if it can help people with kidney disease who have moderate to severe itchiness. The trial has two parts, the first is 12 weeks to see if the drug works and the second is up to 52 weeks to see if the drug has any long term effects.
Who is the study for?
This trial is for adults with advanced stage 4 or 5 chronic kidney disease who have been dealing with daily itching for at least six months and haven't found relief from topical treatments. It's not open to those about to undergo dialysis, receive a kidney transplant, or who have recently changed their itch medication.Check my eligibility
What is being tested?
The study tests if Difelikefalin tablets can reduce itch intensity in patients compared to a placebo. Participants will be randomly assigned to either the drug or placebo group and evaluated over a 12-week period, followed by an optional extension phase of up to one year.See study design
What are the potential side effects?
While specific side effects are not listed here, participants may experience adverse reactions related to Difelikefalin which could include typical drug-related symptoms such as nausea, dizziness, or headaches.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had itchy skin almost every day for the last 6 months.
Select...
My itchiness didn't improve with creams or lotions.
Select...
My kidney disease is in stage 4 or 5.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't started or changed itch treatment in the last 14 days.
Timeline
Screening ~ 4 weeks1 visit
Treatment ~ 12 weeks4 visits
Follow Up ~ 1 weeks1 visit
Screening ~ 4 weeks
Treatment ~ 12 weeks
Follow Up ~1 weeks
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
Logistics
Travel, including flights, are covered
Your expenses for travel tickets for this trial will be reimbursed.
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
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:- I haven't started or changed itch treatment in the last 14 days.I am scheduled for a kidney treatment like dialysis or transplant.I am currently undergoing dialysis.I have had itchy skin almost every day for the last 6 months.My kidney disease is in stage 4 or 5.My itchiness didn't improve with creams or lotions.
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 1 awards, including:- 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 4 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 12 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 1 Weeks after you stop receiving the treatment.
Itching Patient Testimony for trial: Trial Name: NCT05356403 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment actively looking for individuals to test its treatments on?
"Yes, this research is still looking for participants. According to the website clinicaltrials.gov, the trial was originally posted on August 26th, 2022 and updated September 27th, 2022."
Answered by AI
Are patients under the age of 20 eligible for this clinical trial?
"As per the requirements for this study, volunteers must be between 18-85 years old."
Answered by AI
Has Difelikefalin 1 mg Oral Tablet earned FDA approval?
"Difelikefalin 1 mg Oral Tablet has received a 3 for safety. This is based on the fact that it is currently in Phase 3 trials, indicating that there is some efficacy data as well as multiple rounds of safety data."
Answered by AI
Who else is applying?
What state do they live in?
Minnesota
Illinois
What site did they apply to?
Other
Cara Therapeutics Study Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
porque no me dan nada. I would like to slow the progress of this disease. I'm interested in the CKD research study. I have stage III.
PatientReceived 2+ prior treatments
Looking for a drug that will be an effective treatment for the chronic itchiness that accompanies my Stage 3 CKD.
PatientReceived no prior treatments
I have the chronic kidney disease stage 3. My hr goes up my feet swell when I’m standing or sitting for a period of time. They can’t find nothing.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How many screening visits are there?
PatientReceived 1 prior treatment
How responsive is this trial?
Most responsive sites:
- Cara Therapeutics Study Site: < 24 hours
Average response time
- < 2 Days
Typically responds via
Phone Call
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