Uremic pruritus
Conditions
Interventions
Experimental group:Treated with Kriga Bahrain capsules 20mg QD
Sponsors
Zhujiang Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age 18 years old or above (including 18 years old), gender is not limited; 2.Patients with chronic kidney disease (CKD) stage 5; 3.Receive regular hemodialysis; 4.Diagnosed with uremic pruritus of moderate or higher grade and lasting more than 3 months; 5.The Numeric Rating Scale (WI-NRS) score of the worst pruritus in the past 24 hours was assessed at screening >= 4 points; 6.Able to understand the procedures and methods of this trial, willing to strictly abide by the clinical study protocol to complete this trial, and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Itching disorders diagnosed by researchers as being unrelated to uremic pruritus (including but not limited to generalized or localized pruritus not caused by uremia/dialysis, such as pruritus resulting from biliary cirrhosis, hyperthyroidism or hypothyroidism, blood diseases, diabetes, malignant tumors, infections, or neuropathic, somatoform pruritus, etc.) may confuse the assessment of uremic pruritus. 2.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. 3.Subjects with chronic systemic diseases were evaluated by the researchers for potential impact on their participation in the study, including but not limited to: (1) Severe cardiopulmonary diseases, such as unstable angina pectoris, myocardial infarction, severe arrhythmia, World Health Organization (WHO) cardiac function classification of grade III-IV at screening, poorly controlled hypertension despite active treatment with systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at screening; recurrent asthma, etc. (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. 4.Severe hematologic and hepatic abnormalities, consistent with any of the following clinical laboratory test results: (1) Hematology: neutrophil 2.5×upper limit of normal (ULN); or total bilirubin (TBIL) >1.5×ULN; (3) Creatine kinase >2.0×ULN. 5.Known history of drug abuse and/or alcohol abuse: more than 14 servings of alcohol per week (1 serving equivalent to 360 mL of beer, or 45 mL of spirits with 40% alcohol, or 150 mL of wine). 6.Subjects with any active infection at screening who, in the opinion of the investigator, are not suitable for inclusion. 7.Positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) at screening: (further test must be performed by hepatitis B virus DNA deoxyribonucleic acid HBV DNA titer or hepatitis C virus ribonucleic acid HCV RNA test), positive human immunodeficiency virus antibody (HIV Ab), positive serum treponemal antibody (TP Ab) (further treponemal titer must be checked, if positive, it needs to be ruled out). 8.Those who have used prohibited drugs before screening, or changed the restricted concomitant drugs within 30 days before screening; If the subject has used a prohibited drug before screening, the drug must be discontinued for at least 5 half-lives (the specific half-life is subject to the instructions) before the screening visit before screening, and the drug must be discontinued throughout the study period. 9.Prior use of pregabalin = 300 mg/day or gabapentin =1200 mg/day, with claims of lack of clinical efficacy. 10.Known history of hypersensitivity to investigational drug or salvage drug components or other chemically similar drugs or excipients. 11.Those who have had suicidal behavior or suicidal tendencies in the past. 12.Females who are pregnant, preparing to become pregnant during the study, or breastfeeding; Subject is unwilling to use reliable contra
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Worst Itch Numeric Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| The 5-D itch scale;Pittsburgh sleep quality index;Patient Global Impressions scale;Dermatology Life Quality Index;Blood routine;Serum pregnancy test (for women of childbearing age only);Vital signs;physical examination;Blood biochemistry;Urine test;Electrocardiogram;Serology of infectious diseases;Thyroid function tests; | — |
Countries
China
Contacts
Public ContactFengxian Li
Zhujiang Hospital of Southern Medical University
Outcome results
None listed