chronic kidney disease associated Pruritus
Conditions
Interventions
Nalfurafine Hydrochloride Orally Disintegrating Tablets group:Nalfurafine Hydrochloride Orally Disintegrating Tablets 2.5 µg, once daily, for 14 consecutive days
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: When signing the informed consent form: (1) Patients with chronic kidney disease stages 3-5 (non-dialysis) who are not expected to have significant treatment changes or rapid disease progression during the clinical trial. (2) Patients whose pruritus treatment (including topical treatments like emollients/moisturizers, systemic treatments like antihistamines or antiepileptics, and non-drug therapies) has been ineffective in the year prior to signing the informed consent form. (3) Patients aged 18 years or older (including 18 years) and younger than 80 years (including 80 years) at the time of signing the informed consent form, with no gender restriction. For formal registration and enrollment: (4) During the last 7 days of the screening period, the number of days with VAS values measured at both waking and bedtime should be at least 5 days, with the average of the higher VAS values from morning and evening measurements not less than 50 mm. (5) During the last 7 days of the screening period, the number of days with the higher VAS values from morning and evening measurements (if there is a missing measurement at waking or bedtime, then the available measurement should be used) not less than 20 mm should be at least 5 days. (6) During the last 7 days of the screening period, the number of days with pruritus severity evaluated by the Shiratori-Kawashima scale at both waking and bedtime should be at least 5 days, with at least 2 days (including) having a maximum pruritus score of not less than 3 (moderate) at either waking or bedtime.
Exclusion criteria
Exclusion criteria: (1) Patients with abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), or total bilirubin levels within 6 months prior to screening. (2) Patients whose pruritus is not caused by chronic kidney disease, including allergic skin diseases (atopic dermatitis, urticaria, eczema, drug eruptions, etc.), physical skin diseases (heat rash, sun rash, etc.), infectious skin diseases (insect bite dermatitis, chickenpox, measles, impetigo, tinea, etc.), and cholestatic liver diseases. (3) Patients currently receiving or planning to receive dialysis treatment within 3 months. (4) Patients planning to undergo arteriovenous fistula surgery, kidney transplantation, or other elective surgeries within 3 months. (5) Patients with severe cardiovascular diseases: New York Heart Association (NYHA) class III or IV, acute myocardial infarction, unstable angina, massive pericardial effusion, severe arrhythmias, or abnormal electrocardiograms deemed unsuitable for enrollment by the investigator within 6 months prior to screening. (6) Patients with active malignant tumors or those who have received radiotherapy, chemotherapy, targeted therapy, or immunotherapy within 12 months prior to screening. (7) Patients with uncontrolled or medically treated fungal, bacterial, viral, or other infections, including patients undergoing antitubercular treatment for tuberculosis or known to be infected with human immunodeficiency virus (HIV). (8) Patients with hypertension that is poorly controlled by medication: systolic blood pressure >=180 mmHg or diastolic blood pressure >= 110 mmHg. (9) Patients using corticosteroids and immunosuppressants (excluding topical applications). (10) Patients with mental illness or cognitive impairment who cannot accurately understand the VAS score or describe their own sensations. (11) Patients using medications that may affect sleep (such as quinolones, clarithromycin, etc.) within 2 weeks prior to screening. (12) Patients who have received phototherapy for pruritus within 1 month prior to screening. (13) Patients who have previously participated in clinical studies of nalfurafine hydrochloride. (14) Patients who have participated in other clinical studies (including investigational drugs or medical devices) within 3 months prior to screening. (15) Pregnant or lactating women, those with a positive pregnancy test, or women of childbearing potential who do not agree to use contraception during the study period. (16) Other patients deemed unsuitable for participation in this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in VAS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Pruritus Score Based on the Shiki-Kawashima Pruritus Severity Assessment Method;Mean VAS Value for Each Evaluation Period;Mean Pruritus Score Based on the Shimizu-Kawashima Itch Severity Evaluation Method;Improvement in Quality of Life Score;Improvement of sleep quality;VAS improvement degree; | — |
Countries
China
Contacts
Public ContactXiaoqiang Ding
Zhongshan Hospital, Fudan University
Outcome results
None listed