Moderate to severe pruritus related to chronic kidney disease (CKD-aP) in adults undergoing hemodialysis
Conditions
Interventions
The experimental group was 0.5ug/KG:Intravenous injection of the drug
Placebo group:Intravenous injection of the drug
The experimental group was 1ug/KG:Intravenous injection of the drug
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Male and female subjects aged >=18 years old (including 18 years old, based on the time of signing the informed consent form); 2.During the screening period, the local dry weight was>=45.0 kg and ==5 points (i.e., moderate to severe pruritus was consistent at baseline) (Screening period log card); 5.Within 6 months before screening, on different dialysis days, at least 2 single-cell Kt/V measurements >=1.2, or at least 2 urea reduction rate measurements >=65%, or 1 single-cell Kt/V measurement >=1.2 and 1 urea reduction rate measurement >=65% (check); 6.The subjects agreed to take effective contraceptive measures during their participation in the trial (from signing the informed consent form to completing the safety follow-up) and within one month after the end of the trial to avoid pregnancy for themselves or their partners. 7.The subjects were able to maintain good communication with the researchers, fully understand the purpose, process and risks of the trial, etc., agreed to abide by all the requirements of the clinical trial and voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Itching occurred only during dialysis or was limited to local itching in the palm (inquiry and log card); 2.Dialysis treatment was non-compliant. The researchers judged that it might affect the medication compliance of this trial (inquiry and treatment history). 3.The subjects had diseases/medical histories that would increase the risk of the test or affect the evaluation of therapeutic effects: allergic constitution (allergic to three or more foods or drugs) or severe specific allergic diseases/medical histories (such as asthma, etc.) or drug allergy histories (especially opioid drug allergies) (inquired); (2)Have a history of malignant tumors within the past 5 years (except for patients with no recurrence after surgery for basal cell carcinoma and squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the prostate or papillary thyroid carcinoma); (3)The following cardiovascular diseases occurred in the 6 months prior to the screening period, such as significant systolic or diastolic heart failure (such as congestive heart failure on the New York Heart Association's Cardiac Function Classification IV), myocardial infarction, coronary artery bypass grafting or coronary stent implantation, or a history of severe arrhythmia; (4)Severe dialysis-related adverse reactions (medical history) such as imbalance syndrome, malignant arrhythmia, hypoglycemia with consciousness disorder, and gastrointestinal bleeding occurred within 3 months before screening; (5)When screening, other diseases with pruritus symptoms were combined, such as urticaria, neurodermatitis, eczematous dermatitis, cholestasis causing pruritus, etc. (Inquiry and medical history); (6)Screening with hyperthyroidism (examination and medical history); (7)At the time of screening, the conditions of anxiety disorders and depression were poorly controlled, or stable treatment was less than 4 weeks, or it was expected that the treatment plan needed to be changed during the study period, or the researcher considered them unsuitable for inclusion (inquiry and medical history); (8)At the time of screening, there were concurrent encephalopathy, or severe primary diseases of the cardiovascular system, nervous system and other systems, or complications of uremia (inquiry and medical history); (9) During the screening period, liver function ALT or AST > 2.5 times the upper limit of the normal reference value, or TBil > 2 times the upper limit of the normal reference value, or blood sodium > 155mmol/L, or hemoglobin 800pg/mL (examination); (10)Upper limb blood pressure in the supine position during the screening period: systolic blood pressure 180mmHg, or diastolic blood pressure >110mmHg (transient increase or decrease in blood pressure during dialysis may be excluded), and blood pressure abnormalities (examination) considered unsuitable for inclusion by the researcher; (11)Severe arrhythmias indicated by electrocardiogram during the screening period that require treatment; 4.Certain treatments received by the subjects may increase the trial risk or affect the efficacy evaluation: (1)The hemoperfusion regimen was adjusted within 3 months before screening or it is expected that the hemoperfusion regimen needs to be adjusted during the treatment period; (2)Have received ultraviolet B exposure, opioid drugs within 2 weeks before screening, or are expected to rec
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with a weekly mean decrease of >4 points from baseline in WI-NRS at week 12 of treatment.; | — |
Countries
China
Contacts
Public Contactbj-user
Peking University People's Hospital
Outcome results
None listed