| Trial ID: | L1610 |
| Source ID: | NCT05135390
|
| Associated Drug: |
Hsk21542
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| Title: |
A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients with Chronic Kidney Disease-Associated Pruritus
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Pruritus|Hemodialysis Patients with Moderate-to-Severe Pruritus
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| Interventions: |
DRUG: HSK21542|DRUG: Placebo
|
| Outcome Measures: |
Primary: Proportion of subjects with an improvement of ≥ 4 points 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 | Secondary: 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 12|Change from baseline in subjects' quality of life (evaluated using the 5-D itch scale) ., 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., Double-blind Phase：week 12,；Open-label Extension Phase: week 24, 40|Proportion of subjects with an improvement of ≥ 3 points 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
|
| Sponsor/Collaborators: |
Sponsor: Haisco Pharmaceutical Group Co., Ltd.
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| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
545
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-06-17
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| Completion Date: |
2024-06-06
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| Results First Posted: |
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| Last Update Posted: |
2024-12-31
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| Locations: |
Zhong Da Hospital Southeast University, Nanjing, Jiangsu, China|The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05135390
|
