PruritusPhase 2NCT06290375
A Study of HSK21542 in a Peritoneal Dialysis Pruritus Population.
A Phase 2 study testing HSK21542 tablet in people with Pruritus, run by Xizang Haisco Pharmaceutical Co., Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pruritus
- What is being tested?
- HSK21542 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 8 Mar 2024to 11 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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：
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- 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；
- Blood sodium > 155 mmol/L at screening；
- Hemoglobin < 80 g/L at screening；
- 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；
- New or change of treatment received including antihistamines (except for otic or ophthalmic preparations), systemic or topical corticosteroids (except for otic or ophthalmic preparations),calcineurin inhibitors , gabapentin or pregabalin within 7 days prior to screening or anticipating inevitable treatment regimen adjustment during the study;
- Subjects were receiving UV treatment or were expected to receive this treatment during the trial；
- 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；
- A history of substance abuse, drug use, and/or alcohol abuse, defined as drinking an average of >2 units of alcohol per day within 3 months prior to screening (1 unit =360mL of 5% beer or 45mL of 40% liquor or 150mL of wine)；
- 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)；
- Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody at screening；
- Females who are pregnant or breastfeeding；
- Subjects with any other factors considered by the investigator to be ineligible for participation in this clinical study。
About this study
Official title: A Multi-center Stage II Trial to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile of HSK21542 Tablets for the Treatment of Moderate-to-severe Pruritus in Peritoneal Dialysis Subjects
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
- Being tested
- HSK21542 tablet, Placebo
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK21542 tabletDrug
once-daily
PlaceboDrug
once-daily
| Study group | Role | What they receive |
|---|---|---|
| HSK21542 tablet 2mg | Experimental | Not described Receives: Drug: HSK21542 tablet |
| Placebo | Experimental | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 12
Secondary outcomes (2)
Change from baseline in subjects' quality of life (evaluated using the Skindex-10 scale ) after 12 weeks of treatment.
The Skindex-10 Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past week. The questions cover 3 domains: symptoms, emotions, and functioning domain. A lower total score represents better quality of life.
Measured: 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.
The 5-D Itch Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past 2 weeks. The questions cover five dimensions of itch including the degree, duration of itch/day, direction (improvement/worsening), disability (impact on activities such as work), and body distribution of itch. A lower total score represents better quality of life
Measured: Week 2、4、8、12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start8 Mar 2024 (estimated)
- Primary completion8 Mar 2024 (estimated)
- Study completion11 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xizang Haisco Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290375
- Sponsor's protocol ID
- HSK21542-T-202
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Stage II Trial to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile of HSK21542 Tablets for the Treatment of Moderate-to-severe Pruritus in Peritoneal Dialysis Subjects
- ClinicalTrials.gov ID
- NCT06290375
- Acronym / sponsor ID
- HSK21542-T-202
- Conditions
- Pruritus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Xizang Haisco Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2024 (estimated)
- Primary completion
- 8 Mar 2024 (estimated)
- Study completion
- 11 Apr 2025 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSK21542 tablet 2mg | Experimental | Drug: HSK21542 tablet |
| Placebo | Experimental | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK21542 tabletonce-daily | Drug | HSK21542 tablet 2mg |
| Placeboonce-daily | Drug | Placebo |
Primary outcome
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.
Time frame: Week 12
In the NRS score, 0-10 represents different degrees of itching, the larger the number, the more severe the itching
2 secondary outcomes
Change from baseline in subjects' quality of life (evaluated using the Skindex-10 scale ) after 12 weeks of treatment.
Time frame: 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.
Time frame: Week 2、4、8、12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HSK21542 tablet in people with Pruritus, run by Xizang Haisco Pharmaceutical Co., Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.