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

Inclusion Criteria:

• Subjects with chronic kidney disease (CKD) on HD 3 times weekly for ≥12 weeks priorto the informed consent procedure (including the date of informed consent) who cancontinue HD without changing its frequency or method.

• If female, is not pregnant, or nursing.

• If female:

1. Is surgically sterile; or

2. Has been amenorrhoeic for at least 1 year and is over the age of 55 years; or

3. Has a negative serum pregnancy test within 7 days before first dose ofinvestigational product and agrees to use acceptable contraceptive measures (e.g., hormonal contraceptives, barrier with spermicide, intrauterine device,vasectomised partner, or abstinence) from the time of informed consent until 7days after the last dose of investigational product.

• If male, agrees not to donate sperm after the first dose of investigational productadministration until 7 days after the last dose of investigational product, andagrees to use a condom with spermicide or abstain from heterosexual intercourseduring the study until 7 days after the last dose of investigational product.

• Subjects with a prescription dry body weight between 40 and 100 kg, inclusive.

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 hepaticcirrhosis.

• Subject is receiving ongoing ultraviolet B treatment and anticipates receiving suchtreatment during the study.

• Significant systolic or diastolic heart failure (e.g., New York Heart AssociationClass IV congestive heart failure)

• Subjects with concurrent malignancy except excised basal cell or squamous cellcarcinoma of the skin, or carcinoma in situ that has been excised or resectedcompletely.

• Known or suspected history of alcohol, narcotic, or other drug abuse, or substancedependence within 12 months prior to screening.

• Severe mental illness or cognitive impairment (e.g., dementia) or other concurrentmental disorder that, in the opinion of the Investigator, would compromise thevalidity of study measurements.

• Any other relevant acute or chronic medical or neuropsychiatric condition within 3months prior to screening (e.g., diagnosis of encephalopathy, coma, delirium).

• New or change of treatment received for itch including antihistamines andcorticosteroids (oral, IV, or topical) within 14 days prior to screening.

• New or change of prescription for opioids, gabapentin, or pregabalin within 14 daysprior to screening.

• Subject is receiving prohibited medication (e.g., nalfurafine hydrochloride, opioidantagonists)