Back to resultsA Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus
Primary Purpose
Uremic Pruritus in Hemodialysis Patients
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
SK-1405 high dose
SK-1405 low dose
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Uremic Pruritus in Hemodialysis Patients focused on measuring Uremic Pruritus
Eligibility Criteria
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
Sites / Locations
- Investigational site (there may be other sites in this country)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
SK-1405 high dose
SK-1405 low dose
Placebo
Arm Description
SK-1405 high dose is to be administered orally once daily for 2 weeks
SK-1405 low dose is to be administered orally once daily for 2 weeks
Placebo is to be administered orally once daily for 2 weeks
Outcomes
Primary Outcome Measures
Change from baseline in Worst-itching Visual Analog Scale (VAS)
Secondary Outcome Measures
Change from baseline in Worst-itching Visual Analog Scale (VAS)
Change from baseline in Itch Severity Assessment
Change from baseline in Sleep Quality Assessment
Change from baseline in 5D Itch Scale
Number of Participants with Adverse Events
Full Information
NCT ID
NCT03218501
First Posted
July 13, 2017
Last Updated
March 7, 2019
Sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03218501
Brief Title
A Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus
Official Title
A Phase II, Double-Blind, Randomized, Placebo-Controlled Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
August 28, 2017 (Actual)
Primary Completion Date
May 25, 2018 (Actual)
Study Completion Date
May 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremic Pruritus in Hemodialysis Patients
Keywords
Uremic Pruritus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
269 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SK-1405 high dose
Arm Type
Active Comparator
Arm Description
SK-1405 high dose is to be administered orally once daily for 2 weeks
Arm Title
SK-1405 low dose
Arm Type
Active Comparator
Arm Description
SK-1405 low dose is to be administered orally once daily for 2 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo is to be administered orally once daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
SK-1405 high dose
Intervention Description
SK-1405 high dose is to be administered orally once daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
SK-1405 low dose
Intervention Description
SK-1405 low dose is to be administered orally once daily for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is to be administered orally once daily for 2 weeks
Primary Outcome Measure Information:
Title
Change from baseline in Worst-itching Visual Analog Scale (VAS)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in Worst-itching Visual Analog Scale (VAS)
Time Frame
1 week, 3 weeks
Title
Change from baseline in Itch Severity Assessment
Time Frame
1 week, 2 weeks, 3 weeks
Title
Change from baseline in Sleep Quality Assessment
Time Frame
1 week, 2 weeks, 3 weeks
Title
Change from baseline in 5D Itch Scale
Time Frame
2 weeks
Title
Number of Participants with Adverse Events
Time Frame
5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Investigational site (there may be other sites in this country)
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus
We'll reach out to this number within 24 hrs