Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
Condition: Uremic Pruritus
MeSH terms: Pruritus
Intervention: CR845
Intervention description: IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 288.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CR845; difelikefalin; Pruritus; Chronic Itch; Itch; Itching; hemodialysis; Uremic Pruritus; Dialysis; CKD; CKD-associated pruritus; CKD-aP; ESRD (end stage renal disease); Chronic Kidney Disease; Kidney failure, chronic; Kidney dysfunction; Generalized pruritus

Summary:

      This is an open-label multicenter, long-term extension safety study to evaluate the safety of
      IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible for inclusion into the study, a patient must meet the following criteria:

          1. Willing and able to provide written informed consent prior to participating in this
             study;

          2. Able to communicate clearly with the Investigator and staff, able to understand the
             study procedures, and able and willing to comply with the study schedules and all
             study requirements;

          3. Males or females 18 years of age or older;

          4. Currently on hemodialysis for end-stage renal disease and has been categorized as
             experiencing moderate to severe uremic pruritus;

          5. If female:

               1. Is not of childbearing potential (surgically sterile or postmenopausal, as
                  defined in Section 6.5.1.6); or

               2. Has a negative serum pregnancy test at screening and agrees to use acceptable
                  contraceptive measures (as defined in Section 6.5.1.6) from the time of informed
                  consent until the safety Follow-up Visit or 7 days after the last dose of study
                  drug, whichever is later.

          6. If male, agrees not to donate sperm after the first dose of study drug until 7 days
             after the last dose, and agrees to use a condom with spermicide or abstain from
             heterosexual intercourse during the study until 7 days after study drug
             administration. (Note: No restrictions are required for a vasectomized male provided
             his vasectomy was performed ≥4 months prior to dosing);

          7. Has a dry body weight of ≥40.0 kg at screening (prescription target dry body weight);

          8. Has adequacy of dialysis, defined as meeting 1 of the following criteria during the 3
             months prior to screening:

               1. ≥2 single pool Kt/V measurements ≥1.2; or

               2. ≥2 urea reduction ratio measurements ≥65%; or

               3. 1 single pool Kt/V measurement ≥1.2 and 1 urea reduction ratio measurement ≥65%

        Exclusion Criteria:

        A patient will be excluded from the study if any of the following criteria are met:

          1. Received an investigational drugwithin 30 days prior to the first dose of study drug,
             or is planning to participate in another interventional clinical study while enrolled
             in this study.

          2. Has a concomitant disease or any medical condition that, in the opinion of the
             Investigator, could pose undue risk to the patient, impede completion of the study
             procedures, or would compromise the validity of the study measurements, including, but
             not limited to:

               1. Known or suspected history of Diagnostic and Statistical Manual of Mental
                  Disorders, Fifth Edition, -diagnosed alcohol, narcotic or other drug abuse, or
                  substance dependence within 12 months prior to screening;

               2. New York Heart Association Class IV congestive heart failure (Appendix 1, Section
                  14.0);

               3. Severe mental illness or cognitive impairment (eg, dementia);

               4. Any other relevant acute or chronic medical or neuropsychiatric condition;