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

This is an interventional treatment trial for Uremic Pruritus Read More

Inclusion Criteria:

1. 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;
2. 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;
3. Patients who had received treatment in inclusion criteria (2) but did not respond;
4. When signing the informed consent, the patient is older than 18 years old (including 18 years old), regardless of gender;
5. 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;
6. 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;
7. 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:

1. Malignant tumor patients;
2. Patients with mental illness or mental retardation who cannot correctly understand the VAS score and describe their feelings;
3. Patients with alanine aminotransferase (ALT), aspartate aminotransferase (AST) or glutamine transferase (GGT) or total bilirubin higher than twice the upper limit of normal value (ULN) at the screening stage;
4. Patients currently suffering from atopic dermatitis or chronic urticaria;
5. Patients allergic to opioids;
6. Patients with drug or alcohol dependence;
7. Patients who had received light therapy for pruritus within 1 month prior to signing the informed consent;
8. Patients who have participated in a previous clinical study of Nalfurafine Hydrochloride and have taken Nalfurafine Hydrochloride, or who have participated in this clinical study and have been officially enrolled;
9. Participated in other clinical studies (including research drugs and medical devices) within 1 month before signing the informed consent;
10. Pregnant women, lactating women, women who have a positive pregnancy test or who do not agree to use contraception during the study period;
11. Patients who, as determined by the investigator, could not have their VAS score recorded by themselves for any reason;
12. Patients whose comorbidities or previous medical history, as determined by the investigator, would affect the evaluation of this clinical study;
13. After testing, human immunodeficiency virus antibody positive;
14. Other patients judged by the investigator to be unsuitable for participation in this clinical study.