CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
Chronic Kidney Diseases, Pruritus
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring difelikefalin, CR845, Pruritus, Chronic Itch, Itch, Itching, uremic pruritus, CKD, CKD-aP, CKD-associated pruritus, Chronic Kidney Disease, Kidney dysfunction, Generalized pruritus, Hemodialysis, Dialysis, ESRD (end stage renal disease), Kidney failure, chronic
Eligibility Criteria
Inclusion Criteria:
To be eligible for inclusion into the study, a patient must meet the following criteria:
- Advanced stage 4 and 5 CKD not currently on dialysis
- 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.
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 Criteria:
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 screening.
Sites / Locations
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
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- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SitesRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study Site 2Recruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study Site 2Recruiting
- Cara Therapeutics Study SiteRecruiting
- Cara Therapeutics Study SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Difelikefalin 1 mg Oral Tablet
Placebo Oral Tablet
Patients receive oral difelikefalin 1 mg once daily
Patients receive oral placebo once daily