Difelikefalin 1 mg Oral Tablet for Itching

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Itching+1 MoreDifelikefalin 1 mg Oral Tablet - Drug
Eligibility
18 - 85
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Itching
  • Chronic Kidney Disease

Treatment Effectiveness

Effectiveness Progress

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

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

Safety Progress

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

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 · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have experienced 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.
You have a WI-NRS score of at least 4 during the 7-day Run-in Period.