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A 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
Sanwa Kagaku Kenkyusho Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uremic Pruritus in Hemodialysis Patients focused on measuring Uremic Pruritus

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 13, 2017
Last Updated
March 7, 2019
Sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.
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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

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