A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
Condition: Chronic Kidney Diseases; Pruritus
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Pruritus
Intervention: CR845 0.25 mg Oral Tablet; CR845 0.5 mg Oral Tablet; CR845 1 mg Oral Tablet; Placebo Oral Tablet
Intervention description: CR845 0.25 mg medication taken orally 1 time/day; CR845 0.5 mg medication taken orally 1 time/day; CR845 1 mg medication taken orally 1 time/day; Placebo tablet taken orally 1 time/day
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo controlled study
Masking: Double (Participant, Investigator)
Masking description: CR845 will be provided as enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose.
CR845 tablets will be provided at doses of 0.25, 0.5, and 1 mg.
Enrollment: 269.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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

Summary:

      This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the
      safety and efficacy of 3 dose levels of oral CR845 compared to placebo in reducing the
      intensity of itch in chronic kidney disease (CKD) patients with moderate-to-severe pruritus.
      This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week Treatment
      Period, and a Follow-up Visit (approximately 7 days after the last dose of study drug).
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible for inclusion into the study, a patient must meet the following criteria:

          -  CKD patients with stage III, IV, or V (ie, moderate renal impairment with estimated
             glomerular filtration rate (GFR) ≥30 and <60 mL/min/1.73 m2 or severe renal impairment
             with estimated GFR <30 mL/min/1.73 m2).

          -  For severe CKD patients on hemodialysis, they must be receiving hemodialysis 3 times
             per week for at least 3 months prior to the start of screening;

          -  Prior to randomization:

               1. Has completed at least 4 Worst Itching Intensity NRS worksheets from the start of
                  the 7-day Run-in Period;

               2. Has a mean baseline Worst Itching Intensity NRS score ≥5, defined as the average
                  of all non-missing scores reported from the start of the 7-day Run-in Period.

        Exclusion Criteria:

        A patient will be excluded from the study if any of the following criteria are met:

          -  Patients not currently on dialysis who are likely to initiate routine dialysis during
             study participation;

          -  Scheduled to receive a kidney transplant during the study;

          -  New or change of treatment received for itch including antihistamines and
             corticosteroids (oral, intravenous [IV], or topical) within 14 days prior to
             screening;

          -  Received another investigational drug within 30 days prior to the start of screening
             or is planning to participate in another clinical study while enrolled in this study;

          -  Received ultraviolet B treatment within 30 days prior to the start of screening or
             anticipates receiving such treatment during the study;

          -  Participated in a previous clinical study with CR845.