A Study of HSK21542 in a Peritoneal Dialysis Pruritus Population.

NCT06290375 | Not Yet Recruiting Phase 2

• 1 other identifier: HSK21542-T-202
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pruritus

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change from baseline in subjects' quality of life (evaluated using the Skindex-10 scale ) after 12 weeks of treatment.

  Week 2、4、8、12

• Change from baseline in subjects' quality of life (evaluated using the 5-D itch scale) after 12 weeks of treatment.

  Week 2、4、8、12

Study Arms (2)

HSK21542 tablet 2mg

EXPERIMENTAL

Drug: HSK21542 tablet

Placebo

EXPERIMENTAL

Drug: Placebo

Interventions

HSK21542 tablet DRUG

once-daily

HSK21542 tablet 2mg

Placebo DRUG

once-daily

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 18 and ≤ 75 years old, male or female;
• Dry weight at screening: 40.0-135.0 kg (inclusive);
• Patients who have received regular peritoneal dialysis for at least 3 months prior to screening；
• 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；
• 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.

You may not qualify if:

• 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：
• Cerebrovascular accident, myocardial infarction, coronary stent implantation, severe systolic or diastolic heart failure (e.g., congestive heart failure in NYHA class III or higher) within the previous 6 months；
• Uncontrolled hypertension at screening was defined as systolic blood pressure \>160mmHg or diastolic blood pressure \>100mmHg；
• Severe mental illness or cognitive impairment (e.g., dementia)；
• Any other relevant acute or chronic neurological or psychiatric condition within 3 months prior to screening that, at the discretion of the investigator, is not suitable for enrollment (e.g., encephalopathy, coma, delirium)；
• Patients with malignancy, but excluding: curable cervical carcinoma in situ, skin basal cell or squamous cell carcinoma, or any other tumors that have been cured (no evidence of disease recurrence within 5 years)；
• Severe uncontrolled infections at screening, including severe abdominal infection, upper respiratory tract infection, lower respiratory tract infection, urinary tract infection, etc；
• Inability to understand and complete the scale assessments required by the study protocol。
• At the screening or baseline, participants have laboratory values that met the following criteria：
• Alanine transaminase (ALT) or AST (aspartate transaminase) \> 2.5 × upper limit of normal (ULN), or total bilirubin \> 2 × ULN at screening；

Sponsors & Collaborators

• Xizang Haisco Pharmaceutical Co., Ltd: lead

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: March 4, 2024
• Study Start: March 8, 2024
• Primary Completion: March 8, 2024
• Study Completion: April 11, 2025
• Last Updated: March 4, 2024

Record last verified: 2024-02