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

Inclusion criteria

• ✓. Subjects who are willing to sign an informed consent form, fully understand the objectives and significance of the trial, and are willing to comply with the trial protocol before any of the study-related procedures start;
• ✓. Aged ≥ 18 years old, male or female;
• ✓. Patients with end-stage renal disease, who have received regular hemodialysis (including hemodiafiltration) 3 times per week for at least 3 months prior to screening (the judgment of regular hemodialysis is subject to the joint medical comment of the investigator and the sponsor);
• ✓. Dry weight at screening: 40.0-135.0 kg (inclusive);
• ✓. On different days of hemodialysis within 6 months prior to administration, at least two occurrences of single-pool urea clearance index (sp Kt/V) ≥ 1.2 or at least two occurrences of urea reduction ratios (URR) ≥ 65%, or one occurrence of sp Kt/V ≥ 1.2 and one occurrence of URR ≥ 65%;
• ✓. Having completed at least 5 assessments of the Worst Itch Numeric Rating Scale from the lead-in period through D-1 and meeting the criteria of baseline itch intensity \> 5 (defined as the average of all non-missing scores from the lead-in period to D-1; scores 0-10 indicates the range from no itch to the worst imaginable itch);
• ✓. Male subjects who agree to use condoms in sexual intercourse during the study and within 3 months after the last dose; female subjects who have been menopausal for at least one year, or who have been sterilized permanently (e.g., fallopian tube occlusion, hysterectomy, bilateral salpingectomy); or women of childbearing potential who agree to take effective contraceptive measures during the study and within 3 months after the last dose, such as oral contraceptives, condoms, and contraceptive films.
• ✓. Dry weight ≥ 40 kg;

Exclusion criteria