Last updated on July 2019

A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pruritus | Chronic Kidney Diseases
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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