Status:
TERMINATED
A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
Lead Sponsor:
Cara Therapeutics, Inc.
Conditions:
Chronic Kidney Diseases
Pruritus
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of oral difelikefalin administered as a 1 mg tablet once daily compared to placebo in redu...
Detailed Description
This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week double-blind Efficacy Assessment Phase (Treatment Period 1), a double-blind Long-term Extension Phase (Treatment Period ...
Eligibility Criteria
Inclusion
- To be eligible for inclusion into the study, a patient must meet the following criteria:
- Advanced stage 4 and 5 CKD and end stage renal disease on hemodialysis
- Subject self-reports experiencing at least near-daily (eg, most days of a week) pruritus for at least 6 months prior to screening.
- Inadequate response to current or prior treatments (including emollients/moisturizers, topical medications, or systemic treatments) for pruritus prior to screening.
- Prior to randomization on Day 1 of Treatment Period 1:
- Has recorded at least 4 WI-NRS scores during the 7-day Run-in Period; and
- Has a mean baseline WI-NRS score ≥ 5, defined as the average of all non-missing scores reported during the 7-day Run-in Period.
Exclusion
- A patient will be excluded from the study if any of the following criteria are met:
- Scheduled to receive a renal replacement therapy (dialysis or kidney transplant) during the study.
- Has a concomitant disease, significant medical condition or physical/laboratory/ECG/vital signs abnormality that, in the opinion of the investigator, puts the subject at undue risk or interferes with interpretation of study results, impedes completion of the study procedures, or compromises the validity of the study measurements.
- New or change of treatment received for itch, including antihistamines and corticosteroids (oral, intravenous, or topical), within 14 days prior to the start of run-in.
Key Trial Info
Start Date :
May 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2024
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT05342623
Start Date
May 17 2022
End Date
February 29 2024
Last Update
May 7 2024
Active Locations (83)
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1
Cara Therapeutics Study Site
Huntsville, Alabama, United States, 35805
2
Cara Therapeutics Study Site
Phoenix, Arizona, United States, 85016
3
Cara Therapeutics Study Site
Surprise, Arizona, United States, 85374
4
Cara Therapeutics Study Site
Anaheim, California, United States, 92801