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This is a two- stage study. Stage I is a multicenter, open-label trial;Stage II was a multi-center, randomized, double-blind, placebo-controlled trial. About 250 maintenance peritoneal dialysis patients with moderate or above pruritus are planned to be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK21542 tablet 2mg | Experimental |
| |
| Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK21542 tablet | Drug | once-daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with an improvement of ≥ 4points from baseline in the weekly average of the daily Worst Itch Numeric Rating Scale (WI-NRS) after 12 weeks of treatment. | In the NRS score, 0-10 represents different degrees of itching, the larger the number, the more severe the itching | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in subjects' quality of life (evaluated using the Skindex-10 scale ) after 12 weeks of treatment. | The Skindex-10 Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past week. The questions cover 3 domains: symptoms, emotions, and functioning domain. A lower total score represents better quality of life. | Week 2、4、8、12 |
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Inclusion Criteria:
Exclusion Criteria:
Having a history of allergy to opioids, such as urticaria ;
Expecting to undergo hematodialysis and/or renal transplantation during the study;
Expecting to undergo parathyroidectomy during the study;
Pruritus that not be caused by CKD or its complications ;
New or change of treatment received for peritoneal dialysis within 3 months prior to screening or anticipating to adjust peritoneal dialysis during the study
Subjects must not have any of the following medical conditions:
At the screening or baseline, participants have laboratory values that met the following criteria:
New or change of medications that may affect the judgment of antipruritic efficacy, including but not limited to antipsychotics, sedative-hypnotics, selective serotonin reuptake inhibitors (SSRIs), anxiolytics, or tricyclic antidepressants within 14 days prior to screening or anticipating inevitable treatment regimen adjustment during the study;
New or change of treatment received including antihistamines (except for otic or ophthalmic preparations), systemic or topical corticosteroids (except for otic or ophthalmic preparations),calcineurin inhibitors , gabapentin or pregabalin within 7 days prior to screening or anticipating inevitable treatment regimen adjustment during the study;
Subjects were receiving UV treatment or were expected to receive this treatment during the trial;
Having used opioids within 7 days before screening, or being unable to avoid the use of opioids other than the investigational drug during the study;
A history of substance abuse, drug use, and/or alcohol abuse, defined as drinking an average of >2 units of alcohol per day within 3 months prior to screening (1 unit =360mL of 5% beer or 45mL of 40% liquor or 150mL of wine);
Having participated in any clinical trial of other drug or medical device within 1 month before screening (received study medication or treated by the medical device in the clinical trial);
Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody at screening;
Females who are pregnant or breastfeeding;
Subjects with any other factors considered by the investigator to be ineligible for participation in this clinical study。
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| Drug |
once-daily |
|
| Change from baseline in subjects' quality of life (evaluated using the 5-D itch scale) after 12 weeks of treatment. | The 5-D Itch Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past 2 weeks. The questions cover five dimensions of itch including the degree, duration of itch/day, direction (improvement/worsening), disability (impact on activities such as work), and body distribution of itch. A lower total score represents better quality of life | Week 2、4、8、12 |
| D013568 | Pathological Conditions, Signs and Symptoms |