Phase 3 Study of Difelikefalin in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus

Exclusion Criteria

• •Planned or anticipated to receive a kidney transplant during the study.
• •Has localised itch restricted to the palms of the hands.
• •Has pruritus only during the dialysis session
• •Subjects with severe hepatic impairment (Child-Pugh Class C) or concurrent hepatic cirrhosis.
• •Subject is receiving ongoing ultraviolet B treatment and anticipates receiving such treatment during the study.
• •Significant systolic or diastolic heart failure (e.g., New York Heart Association Class IV congestive heart failure)
• •Subjects with concurrent malignancy except excised basal cell or squamous cell carcinoma of the skin, or carcinoma in situ that has been excised or resected completely.
• •Known or suspected history of alcohol, narcotic, or other drug abuse, or substance dependence within 12 months prior to screening.
• •Severe mental illness or cognitive impairment (e.g., dementia) or other concurrent mental disorder that, in the opinion of the Investigator, would compromise the validity of study measurements.
• •Any other relevant acute or chronic medical or neuropsychiatric condition within 3 months prior to screening (e.g., diagnosis of encephalopathy, coma, delirium).
• •New or change of treatment received for itch including antihistamines and corticosteroids (oral, IV, or topical) within 14 days prior to screening.
• •New or change of prescription for opioids, gabapentin, or pregabalin within 14 days prior to screening.
• •Subject is receiving prohibited medication (e.g., nalfurafine hydrochloride, opioid antagonists)