Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

Inclusion criteria

• . Willing and able to provide written informed consent prior to participating in this study;
• . 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;
• . Males or females 18 years of age or older;
• . Currently on hemodialysis for end-stage renal disease and has been categorized as experiencing moderate to severe uremic pruritus;
• . If female:
• . Is not of childbearing potential (surgically sterile or postmenopausal, as defined in Section 6.5.1.6); or
• . 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.
• . 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);

Exclusion criteria