Hemodialysis Patients with Moderate-to-Severe Pruritus, Pruritus
Conditions
Keywords
Hemodialysis Patients with Moderate-to-Severe Pruritus, HSK21542
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.
Detailed description
Double-blind Phase The Double-blind Phase of the study will consist of a 28-day Screening Visit, a 7-day Run-in Period, a 12 week Double-blind Treatment Period, and one week Follow-up Period. Informed consent will be obtained prior to performing any study-specific procedures. The Screening Visit will occur within 7 to 28 days prior to randomization to assess eligibility. Open-label Extension Phase Patients who medication compliance ≥ 80% during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will have the option to receive open label HSK21542 for an additional 40 weeks. The Open-label Extension Phase will be comprised of the Open-label Treatment Period and the Follow-up Period. The last dose of open-label study drug will be administered at the last dialysis visit on Week 40, or Early Termination. A final safety Follow up Visit will be conducted 5-9 days after the End of Treatment/Early Termination Visit.
Interventions
DRUGHSK21542
three times per week
DRUGPlacebo
three times per week
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The double-blind phase Inclusion Criteria: 1. 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; 2. Aged ≥ 18 years old, male or female; 3. 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); 4. Dry weight at screening: 40.0-135.0 kg (inclusive); 5. 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%; 6. 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); 7. 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. The 0pen-label extension phase Inclusion Criteria： 1. Dry weight ≥ 40 kg; 2. Complete a double-blind study with medication adherence of ≥ 80%. The double-blind phase
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | week 12 | In the NRS score, 0-10 represents different degrees of itching, the larger the number, the more severe the itching |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in subjects' quality of life (evaluated using the Skindex-10 scale ) after 12 weeks of treatment. | week 12 | 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. |
| 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 | 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. |
| 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 | In the NRS score, 0-10 represents different degrees of itching, the larger the number, the more severe the itching |
Countries
China
Outcome results
None listed