Anrikefon vs Nalfurafine for Sleep Quality in Hemodialysis Patients With CKD-aP

Exclusion Criteria

• •1. Participants with other serious systemic diseases that may affect their ability to participate in the study, as assessed by the investigator, including but not limited to:
• •1. Severe cardiovascular diseases, such as unstable angina, myocardial infarction, severe arrhythmias, World Health Organization (WHO) heart function classification III-IV during screening, poorly controlled hypertension or hypotension despite active treatment, and recurrent asthma.
• •2. A history of cerebrovascular accident (CVA) within the last 6 months.
• •3. Malignant tumors, excluding those that are curable, such as cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin, or any other cancer that has been cured (with no evidence of disease recurrence for 5 years).
• •2. It is expected to undergo kidney transplantation and/or parathyroidectomy during the study period.
• •3. The subjects are currently undergoing ultraviolet B treatment or are expected to receive such treatment during the study period.
• •4. Have participated in any clinical trials of other drugs or medical devices within one month prior to screening (treatment with drugs or medical devices that have received clinical trials).
• •5. Patients who have used the following drugs within 7 days before screening:
• •1. those who have used opioids.
• •2. those who must use opioids other than the investigational drug during the study period.
• •3. those who has used gabapentin, pregabalin and calcineurin inhibitors;
• •4. those who use drugs that can affect the efficacy judgment of anti-itching, including but not limited to antipsychotic drugs, sedative-hypnotic drugs, selective serotonin reuptake inhibitors (SSRIs), anti-anxiety drugs, or tricyclic antidepressants.
• •6. After screening and enrollment, new antihistamines (such as antihistamines and corticosteroids, etc. (oral, intravenous or topical)) were prescribed, or the types, dosages or frequencies of these drugs were changed.
• •7. There is a history of allergy to opioid drugs, or it is known that there is a history of allergy to investigatory drugs or components of remedial drugs or other drugs or excipients with similar chemical structures.
• •8. Severe hematological and liver function abnormalities during screening, meeting any one of the following clinical laboratory test results:
• •1. Hematology: Hemoglobin \< 80g/L.
• •2. Liver function:
• •* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5× upper limit of normal (ULN).
• •* Total bilirubin (TBIL) \> 2×ULN.
• •9. Subjects who had any active infections during screening and whom the researchers considered unsuitable for inclusion (including but not limited to acute hepatitis, skin infections, etc.).
• •10. As determined by the researchers, any other physical or mental illness or condition that may increase the risk of the trial, affect the subjects' compliance with the protocol, or affect the subjects' completion of the trial.