A Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy, safety and dose response of SK-1405 for the treatment of subjects with uremic pruritus receiving hemodialysis, during 2 weeks of treatment.

Official Title
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A Phase II, Double-Blind, Randomized, Placebo-Controlled Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus

Conditions
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Uremic Pruritus in Hemodialysis Patients

Intervention / Treatment
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* Drug: SK-1405 high dose
* Drug: SK-1405 low dose
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receiving hemodialysis three times a week for at least 12 weeks Worst itching VAS in a day is 30 mm or more at least 5 days during the first observation period Mean worst itching VAS is 50 mm or more in both the first and second observation periods Exclusion Criteria: Complications that may affect the assessment of uremic pruritus Started or changed pruritus treatment within 13 days prior to starting observations Received ultraviolet treatment within 27 days prior to starting observations Uncontrollable hypertension, serious liver disease, serious heart disease, stroke, or malignant tumor Depression, schizophrenia, dementia, epilepsia, convulsive seizure, drug addiction, or alcoholism Pregnancy, or breastfeeding

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SK-1405 high dose<br>SK-1405 high dose is to be administered orally once daily for 2 weeks | Drug: SK-1405 high dose<br>* SK-1405 high dose is to be administered orally once daily for 2 weeks<br>|
| Active Comparator: SK-1405 low dose<br>SK-1405 low dose is to be administered orally once daily for 2 weeks | Drug: SK-1405 low dose<br>* SK-1405 low dose is to be administered orally once daily for 2 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo is to be administered orally once daily for 2 weeks | Drug: Placebo<br>* Placebo is to be administered orally once daily for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Worst-itching Visual Analog Scale (VAS) |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Worst-itching Visual Analog Scale (VAS) |  | 1 week, 3 weeks | 
| Change from baseline in Itch Severity Assessment |  | 1 week, 2 weeks, 3 weeks | 
| Change from baseline in Sleep Quality Assessment |  | 1 week, 2 weeks, 3 weeks | 
| Change from baseline in 5D Itch Scale |  | 2 weeks | 
| Number of Participants with Adverse Events |  | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uremic Pruritus