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

NCT05135390 | Completed Phase 3 DMC

• 1 other identifier: HSK21542-302
• Study Type: interventional
• Target: 545
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Hemodialysis Patients with Moderate-to-Severe Pruritus; HSK21542

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  week 12

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

  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.

  week 12

Study Arms (2)

HSK21542

EXPERIMENTAL

0.3 μg/kg

Drug: HSK21542

Placebo

EXPERIMENTAL

Placebo

Drug: Placebo

Interventions

HSK21542 DRUG

three times per week

HSK21542

Placebo DRUG

three times per week

Placebo

Eligibility Criteria

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

You may qualify if:

• 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;
• Complete a double-blind study with medication adherence of ≥ 80%.

You may not qualify if:

• Expecting to undergo renal transplantation and/or parathyroidectomy during the study，or parathyroid hormone \>800 pg/mL;
• Having used opioids within 7 days before screening, or being unable to avoid the use of opioids other than the investigational drug during the study;
• Having participated in any clinical trial of other drug or medical device within 1 month before screening (received study medication or treated by the medical device in the clinical trial);
• New or change of treatment received for hemoperfusion regimen within 3 months prior to screening or anticipating to adjust hemoperfusion regimen during the study;
• Upper extremity blood pressure in a supine position during screening: systolic blood pressure \< 90 mmHg, or diastolic blood pressure \< 60 mmHg, or systolic blood pressure \> 180 mmHg, or diastolic blood pressure \> 110 mmHg;
• Alanine transaminase (ALT) or AST (aspartate transaminase) \> 2.5 × upper limit of normal (ULN), or total bilirubin \> 2 × ULN at screening;
• Blood sodium \> 155 mmol/L at screening;
• Hemoglobin \< 80 g/L at screening;
• Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody at screening;
• Pruritus that may or must not be caused by ESRD or its complications (e.g., patients with pruritic dermatosis or cholestatic liver disease will be excluded);
• New or change of treatment received including antihistamines (oral, intravenous, or topical), systemic or topical corticosteroids (except for otic or ophthalmic preparations) , calcium regulated phosphatase inhibitors, gabapentin, pregabalin, and other combination drugs that are restricted in 5.5.1, or whose treatment regimen must be changed during the expected double-blind study periodwithin 7 days prior to screening or anticipating inevitable treatment regimen adjustment during the study;
• \. New or change of medications that may affect the judgment of antipruritic efficacy, including but not limited to antipsychotics, sedative-hypnotics, selective serotonin reuptake inhibitors (SSRIs), anxiolytics, or tricyclic antidepressants within 14 days prior to screening or anticipating inevitable treatment regimen adjustment during the study; 15. Females who are pregnant or breastfeeding; 16. Any physiological or psychological diseases or conditions that may increase the risk of the trial, affect the subject's compliance with the protocol, or affect the subject's completion of the trial, as judged by the investigator, including but not limited to:
• Local pruritus limited to palms only;
• Pruritus during hemodialysis only;
• History of known or suspected abuse of or dependence on alcohol, narcotics or other drugs within 12 months before screening;

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (2)

Zhong Da Hospital Southeast University

Nanjing, Jiangsu, China

Location

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

Related Publications (1)

• Liu BC, Li ZL, Zhang P, Zhong AM, Bai YL, Xu Y, Gao BH, Li YL, Wang Y, Zhou LH, Yao L, Wang JX, Yan R, Wang L, Liao B, Xie DQ, Yi XM, Guan TJ, Wang CL, Li GS, Li FQ, Chen JH; Anrikefon-302 study collaborator group. Efficacy and safety of anrikefon in patients with pruritus undergoing haemodialysis: multicentre, double blind, randomised placebo controlled phase 3 trial. BMJ. 2025 Aug 19;390:e085208. doi: 10.1136/bmj-2025-085208.

  PMID: 40829896 DERIVED

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 26, 2021
• Study Start: June 17, 2022
• Primary Completion: July 27, 2023
• Study Completion: June 6, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)