A Multi-site Bridging Study of Nalfurafine Hydrochloride Orally Disintegrating Tablet

Inclusion criteria

• ✓. Chronic renal failure patients who have been on stable dialysis for 3 months or more, receive regular hemodialysis 3 times a week, and expect no significant treatment changes or dramatic changes in their condition during the clinical trial;
• ✓. In the 1 year prior to signing the informed consent, patients who were treated with the following drugs A and/or B: (A) Systematic treatment (oral, injection, etc.) of "prescribed drugs for pruritus" (including antihistamines or antiallergic drugs) for more than 2 weeks consecutively; (B). Use of " prescribed drugs for pruritus" (ointments, etc.) or topical treatment of moisturizers prescribed by physicians;
• ✓. Patients who had received treatment in inclusion criteria (2) but did not respond;
• ✓. When signing the informed consent, the patient is older than 18 years old (including 18 years old), regardless of gender;
• ✓. During the observation period before administration (D8-14), the number of days for which the VAS values were measured at the time of getting up and going to bed should not be less than 5 days, and the average value of the larger VAS values in the morning and evening measurements should not be less than 50 mm;
• ✓. During the observation period before administration (D8-14), The number of days in which the larger VAS value measured in the morning and evening measurements (if there was a missing time in getting up or going to bed, the value which has been measured was selected) is not less than 20 mm, was not less than 5 days;
• ✓. During the observation period before administration (D8-14), the number of days in which the pruritus severity of Hsie-Kawashima's was evaluated at the time of getting up and at the time of going to bed was not less than 5 days, in which the maximum of the pruritus score was not less than 3 (moderate) in the morning and evening measurements was more than half.

Exclusion criteria