chronic kidney disease associated pruritus
Conditions
Interventions
Amreliphine group:Injection of Anricifen
Nafurafine group:Oral Nalfurafine
Sponsors
Zhujiang Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Be able to understand the procedures and methods of this trial, be willing to strictly follow the clinical research protocol to complete this trial, and voluntarily sign the informed consent form; 2.Male or female individuals aged 18 or above and 75 or above; 3.Patients with end-stage renal disease received regular hemodialysis three times a week before the screening period (whether they met the requirements for regular dialysis was determined based on the opinions of the researchers). 4.Meet the diagnostic criteria for chronic kidney disease-associated pruritus (CKD-aP); 5.The subjects were evaluated using the Worst Itch Numerical Rating Scale (WI-NRS) for the most severe pruritus intensity and met the baseline pruritus intensity of >= 4 points.
Exclusion criteria
Exclusion criteria: 1.There are other serious systemic diseases that the researchers assessed may affect the subjects' participation in the study, including but not limited to: Suffering from severe heart and lung diseases, such as unstable angina pectoris, myocardial infarction, severe arrhythmia, with a World Health Organization (WHO) cardiac function classification of grade III to IV at the time of screening, hypertension or hypotension that remains poorly controlled despite active treatment, recurrent asthma, etc. There is a history of cerebrovascular accident within 6 months before screening, etc. Patients with malignant tumors, but excluding: curable cervical carcinoma in situ, cutaneous basal cell carcinoma or squamous cell carcinoma, or any other tumors that have been cured (with no evidence of disease recurrence within 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: those who have used opioids, or those who must use opioids other than the investigational drug during the study period; Has used gabapentin, pregabalin and calcineurin inhibitors; The use of 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: Hematology: Hemoglobin 2.5× upper limit of normal (ULN); Or 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Skindex-10 Scale Score;Patient Global Impression of Change Score;12-lead electrocardiogram features;Laboratory Test Results;WI-NRS score;Omics data;5D-itching scale score;Mechanical pain threshold;Adverse events;Kidney Disease Quality of Life Questionnaire Results;Vital signs; | — |
Countries
China
Contacts
Public ContactFengxian Li
Zhujiang Hospital of Southern Medical University
Outcome results
None listed