A Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus
A Phase II, Double-Blind, Randomized, Placebo-Controlled Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus
1 other identifier
interventional
269
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2017
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2017
CompletedFirst Posted
Study publicly available on registry
July 14, 2017
CompletedStudy Start
First participant enrolled
August 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2018
CompletedMarch 8, 2019
November 1, 2018
9 months
July 13, 2017
March 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in Worst-itching Visual Analog Scale (VAS)
2 weeks
Secondary Outcomes (5)
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
Study Arms (3)
SK-1405 high dose
ACTIVE COMPARATORSK-1405 high dose is to be administered orally once daily for 2 weeks
SK-1405 low dose
ACTIVE COMPARATORSK-1405 low dose is to be administered orally once daily for 2 weeks
Placebo
PLACEBO COMPARATORPlacebo is to be administered orally once daily for 2 weeks
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Investigational site (there may be other sites in this country)
Tokyo, Japan
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2017
First Posted
July 14, 2017
Study Start
August 28, 2017
Primary Completion
May 25, 2018
Study Completion
May 25, 2018
Last Updated
March 8, 2019
Record last verified: 2018-11