| 1. Subject is willing and able to provide written informed consent prior to participating in this study.
2. Subject is able to communicate clearly with the study investigator and staff and complete the required study procedures and questionnaires.
3. Subject is 18 to 85 years old, inclusive, at the time of consent.
4. Subject not currently on dialysis who has advanced CKD & Subject receiving hemodialysis 3 times per week for at least 3 months prior to the start of screening.
5. Subject self-reports experiencing at least near-daily (eg, most days of a week) pruritus for at least 6 months prior to screening.
6. Subject reports inadequate response to current or prior treatments (including emollients/moisturizers, topical medications, or systemic treatments) for pruritus prior to screening.
7. Female subject is not pregnant or nursing during any period of the study.
8. If female of childbearing potential, must have a negative serum β-human chorionic gonadotropin pregnancy test result within 7 days prior to randomization.
9. Females of childbearing potential and all males must practice contraception.
10. Subject has, prior to randomization on Day 1 of the Treatment Period: a. At least 4 WI-NRS scores during the 7-day Run-in Period; and b. A mean baseline WI-NRS score ≥5, defined as the average of all nonmissing scores reported during the 7-day Run-in Period.
11.Subject has adequate venous access, as determined by the investigator or designee.
12. To be eligible for inclusion into the Open-label Extension Period of the study, each subject: Has completed the Double-blind Treatment Period of this study & Continues to meet inclusion criteria 1 through 9. |
1. Subject is scheduled to receive a renal replacement therapy (dialysis or kidney transplant) during the study.
2. Subject has a concomitant disease, significant medical condition, or physical/laboratory/ECG/vital sign 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.
3. Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.
4. Subject had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
5. Subject has a history of hypernatremia within the past 3 months.
6. Subject is unable to sense or respond to thirst appropriately.
7.New or change of treatment received for itch, including antihistamines and corticosteroids (oral, intravenous [IV], or topical), within 14 days prior to the start of Run-in.
8. New or change of prescription for gabapentinoids, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, anticonvulsants/mood stabilizers, tricyclic antidepressants, opioids, or benzodiazepines within 14 days prior to the start of Run-in.
9.Subject has serum (ALT) or (AST) >2.5× (ULN) and/or total bilirubin >1.5×ULN at screening.
10.Subject had received an 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.
11.Subject has pruritus attributed to a cause other than CKD (eg, pruritus associated with dermatological, hepatobiliary, neuropathic, and/or hematologic disorders).
12.Subject has localized itch restricted to the palms of the hands.
13.Subject received an opioid antagonist or opioid-mixed agonist-antagonist within 14 days prior to the start of screening and/or anticipates receiving such medications during the study
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Adult: 18 Year(s)-44 Year(s) |
18 Year(s) |
85 Year(s) |
Both |