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Difelikefalin 1 mg Oral Tablet for Itching

Cara Therapeutics Study Site, Boston, MA
Itching+1 More ConditionsDifelikefalin 1 mg Oral Tablet - Drug
Eligibility
18 - 85
All Sexes

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.

Eligible Conditions
  • Itching
  • Chronic Kidney Disease

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

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Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Week 12 of Treatment Period 1

Week 12
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 daily 24-hour WI-NRS score at Week 12 of Treatment Period 1
Efficacy Assessment Phase (Treatment Period 1): Proportion of subjects who are "complete itch responders" defined as subjects with ≥ 70% of the non-missing 24-hour WI-NRS scores equal to 0 or 1 at Week 12 of Treatment Period 1.
Week 4
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.
Week 8
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.

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
Nemolizumab
2
QRX003, 4%
2
EP547 100 mg

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

Difelikefalin 1 mg Oral Tablet
1 of 2
Placebo Oral Tablet
1 of 2

Experimental Treatment

Non-Treatment Group

400 Total Participants · 2 Treatment Groups

Primary Treatment: Difelikefalin 1 mg Oral Tablet · Has Placebo Group · Phase 3

Difelikefalin 1 mg Oral Tablet
Drug
Experimental Group · 1 Intervention: Difelikefalin 1 mg Oral Tablet · Intervention Types: Drug
Placebo Oral Tablet
Drug
PlaceboComparator Group · 1 Intervention: Placebo Oral Tablet · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 12 of treatment period 1

Who is running the clinical trial?

Cara Therapeutics, Inc.Lead Sponsor
22 Previous Clinical Trials
4,933 Total Patients Enrolled
Frédérique Menzaghi, PhDStudy DirectorCara Therapeutics
9 Previous Clinical Trials
1,862 Total Patients Enrolled

Eligibility Criteria

Age 18 - 85 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been feeling itchy almost every day for at least 6 months before the screening.
You have tried other treatments for itching before joining the study, but they did not work well enough.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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