A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients with Chronic Kidney Disease-Associated Pruritus
NCT05135390 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 545
Last updated 2024-12-31
Summary
This is a multi-center, randomized, double-blind, placebo-controlled study. About 544 maintenance hemodialysis patients with moderate or above chronic kidney disease-associated pruritus are planned to be enrolled. They will randomized into the treatment group (HSK21542, 0.3 μg/kg) and the control group (placebo) at a 1:1 ratio.
Conditions
- Pruritus
- Hemodialysis Patients with Moderate-to-Severe Pruritus
Interventions
- DRUG
-
HSK21542
three times per week
- DRUG
-
three times per week
Sponsors & Collaborators
-
Haisco Pharmaceutical Group Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-06-17
- Primary Completion
- 2023-07-27
- Completion
- 2024-06-06
Countries
- China
Study Locations
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