A Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus

A Phase II, Double-Blind, Randomized, Placebo-Controlled Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus

The purpose of this study is to evaluate the efficacy, safety and dose response of SK-1405 for the treatment of subjects with uremic pruritus receiving hemodialysis, during 2 weeks of treatment.

Inclusion Criteria:

• Receiving hemodialysis three times a week for at least 12 weeks
• Worst itching VAS in a day is 30 mm or more at least 5 days during the first observation period
• Mean worst itching VAS is 50 mm or more in both the first and second observation periods

Exclusion Criteria:

• Complications that may affect the assessment of uremic pruritus
• Started or changed pruritus treatment within 13 days prior to starting observations
• Received ultraviolet treatment within 27 days prior to starting observations
• Uncontrollable hypertension, serious liver disease, serious heart disease, stroke, or malignant tumor
• Depression, schizophrenia, dementia, epilepsia, convulsive seizure, drug addiction, or alcoholism
• Pregnancy, or breastfeeding