chronic kidney disease associated pruritus
Conditions
Interventions
experimental group:Oral administration of Crisugabalin at 10 mg QD
Sponsors
Chu Hsien-I Memorial Hospital of Tianjin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old. 2. Patients with chronic kidney disease, receiving hemodialysis. 3. Complicated with chronic kidney disease associated pruritus, the Numeric Rating Scale (WI-NRS) score of the worst pruritus in the past 24 hours was assessed at screening >= 4 points, and plan to undergo treatment with Crisugabalin. 4. Able to understand the procedures and methods of this experiment and voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Some researchers believe that there are situations that may affect the assessment of pruritus, such as the presence of infectious or allergic skin diseases in the affected skin area, which may influence sensation. 2. Neurological and mental disorders that the researchers believed might affect the evaluation of pruritus or self-rating, including epilepsy, recurrent dizziness, headache, memory and cognitive impairment; cerebral vascular accident or transient ischemic attack within 6 months before screening, etc. 3. Severe hematologic and hepatic abnormalities, consistent with any of the following clinical laboratory test results: Hematology: neutrophil 2.5×upper limit of normal (ULN); or total bilirubin (TBIL) >1.5×ULN; Creatine kinase >2.0×ULN. 4. Subjects with any active infection at screening who, in the opinion of the investigator, are not suitable for inclusion. 5. Prior use of pregabalin >= 300 mg/day or gabapentin >=1200 mg/day, with claims of lack of clinical efficacy. 6. Known history of hypersensitivity to investigational drug or salvage drug components or other chemically similar drugs or excipients. 7. Those who have had suicidal behavior or suicidal tendencies in the past. 8. Females who are pregnant, preparing to become pregnant during the study, or breastfeeding. 9. Researchers judge other situations that may affect the conduct and result determination of the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Worst Itch Numeric Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dermatology Life Quality Index;Pittsburgh sleep quality index;Patient Global Impressions scale;The 5-D itch scale; | — |
Countries
China
Contacts
Public ContactXu Min
Chu Hsien-I Memorial Hospital of Tianjin Medical University
Outcome results
None listed