NCT05135390

A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients with Chronic Kidney Disease-Associated Pruritus

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HSK21542 Injection in Maintenance Hemodialysis Patients with Chronic Kidney Disease-associated Pruritus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 545 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Double-blind Phase The Double-blind Phase of the study will consist of a 28-day Screening Visit, a 7-day Run-in Period, a 12 week Double-blind Treatment Period, and one week Follow-up Period. Informed consent will be obtained prior to performing any study-specific procedures. The Screening Visit will occur within 7 to 28 days prior to randomization to assess eligibility. Open-label Extension Phase Patients who medication compliance ≥ 80% during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will have the option to receive open label HSK21542 for an additional 40 weeks. The Open-label Extension Phase will be comprised of the Open-label Treatment Period and the Follow-up Period. The last dose of open-label study drug will be administered at the last dialysis visit on Week 40, or Early Termination. A final safety Follow up Visit will be conducted 5-9 days after the End of Treatment/Early Termination Visit.

Conditions

• Pruritus
• Hemodialysis Patients with Moderate-to-Severe Pruritus

Interventions

Type	Name	Description
DRUG	HSK21542	three times per week
DRUG	Placebo	three times per week

Timeline

• Start date: 2022-06-17
• Primary completion: 2023-07-27
• Completion: 2024-06-06
• First posted: 2021-11-26
• Last updated: 2024-12-31

Locations

2 sites across 1 country: China