Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06290375
Other study ID # HSK21542-T-202
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date March 8, 2024
Est. completion date April 11, 2025

Study information

Verified date February 2024
Source Haisco Pharmaceutical Group Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 250
Est. completion date April 11, 2025
Est. primary completion date March 8, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Aged = 18 and = 75 years old, male or female; 2. Dry weight at screening: 40.0-135.0 kg (inclusive); 3. Patients who have received regular peritoneal dialysis for at least 3 months prior to screening; 4. 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; 5. 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. Exclusion Criteria: 1. Having a history of allergy to opioids, such as urticaria ; 2. Expecting to undergo hematodialysis and/or renal transplantation during the study; 3. Expecting to undergo parathyroidectomy during the study; 4. Pruritus that not be caused by CKD or its complications ; 5. New or change of treatment received for peritoneal dialysis within 3 months prior to screening or anticipating to adjust peritoneal dialysis during the study 6. Subjects must not have any of the following medical conditions: 1. 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; 2. Uncontrolled hypertension at screening was defined as systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg; 3. Severe mental illness or cognitive impairment (e.g., dementia); 4. 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); 5. 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); 6. Severe uncontrolled infections at screening, including severe abdominal infection, upper respiratory tract infection, lower respiratory tract infection, urinary tract infection, etc; 7. Inability to understand and complete the scale assessments required by the study protocol? 7. At the screening or baseline, participants have laboratory values that met the following criteria: 1. Alanine transaminase (ALT) or AST (aspartate transaminase) > 2.5 × upper limit of normal (ULN), or total bilirubin > 2 × ULN at screening; 2. Blood sodium > 155 mmol/L at screening; 3. Hemoglobin < 80 g/L at screening; 8. 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; 9. 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; 10. Subjects were receiving UV treatment or were expected to receive this treatment during the trial; 11. 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; 12. 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); 13. 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); 14. Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody at screening; 15. Females who are pregnant or breastfeeding; 16. Subjects with any other factors considered by the investigator to be ineligible for participation in this clinical study?

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HSK21542 tablet
once-daily
Placebo
once-daily

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Xizang Haisco Pharmaceutical Co., Ltd

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. Week 2?4?8?12
Secondary 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 Week 2?4?8?12
See also
  Status Clinical Trial Phase
Completed NCT05038982 - Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin Phase 2
Completed NCT04510090 - Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus Phase 1
Completed NCT02143973 - Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus Phase 2/Phase 3
Terminated NCT01825655 - Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching Phase 4
Completed NCT01236859 - Gabapentin for Prophylaxis Intrathecal Morphine-Induced Pruritus N/A
Completed NCT00782054 - Evaluation of Post Burn Rehabilitation Population for Itch Control Phase 4
Completed NCT04999787 - A Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of HSK21542 Injection in Liver Disease Subjects With Pruritus Phase 2
Recruiting NCT04256759 - Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus Phase 2
Completed NCT04337073 - The Effect of Propofol on Dexamethasone-induced Perineal Pruritus Early Phase 1
Completed NCT04415034 - Scalp Pruritus Measurement Using Visual Analog Scale and 5-d Itch Scale in Children With Pediculosis Capitis
Active, not recruiting NCT05525520 - Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis Phase 2
Recruiting NCT03340155 - Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases N/A
Completed NCT04399525 - Influence of H1-antihistamines on the Dermal Blood Flow Response to Histamine, Cinnamaldehyde and Capsaicin. N/A
Recruiting NCT02432508 - Efficacy of Laser Acupuncture on Pruritus in Patients With Chronic Kidney Disease Undergoing Hemodialysis N/A
Completed NCT02653703 - L-menthol as a Topical Counter-irritant to TRPA1-induced Neurogenic Inflammation and Pain N/A
Completed NCT01963793 - Topical Aprepitant in Prurigo Patients Phase 2
Completed NCT01232985 - Efficacy and Tolerability Study of Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis in Adults Phase 2
Not yet recruiting NCT00577967 - Gabapentin - A Solution to Uremic Pruritus? N/A
Recruiting NCT06120907 - Swiss Itch Registry
Recruiting NCT04589429 - Adding Nalbuphine for Control of Intrathecal Morphine Pruritus Phase 2