A Study of SK-1405 in Hemodialysis Patients With Uremic P... | NCT03218501

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

NCT03218501

Sponsor

Sanwa Kagaku Kenkyusho Co., Ltd.

Status

Completed

Last Update Posted

Mar 8, 2019Actual

Enrollment

269Actual

Phase

Phase 2

Conditions

Uremic Pruritus in Hemodialysis Patients

Interventions

SK-1405 high dose
SK-1405 low dose
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 28, 2017Actual

Primary Completion Date

May 25, 2018Actual

Completion Date

May 25, 2018Actual

First Submitted Date

Jul 13, 2017

First Submission Date that Met QC Criteria

Jul 13, 2017

First Posted Date

Jul 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2019

Last Update Posted Date

Mar 8, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

269Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SK-1405 high dose	Active Comparator	SK-1405 high dose is to be administered orally once daily for 2 weeks	Drug: SK-1405 high dose
SK-1405 low dose	Active Comparator	SK-1405 low dose is to be administered orally once daily for 2 weeks	Drug: SK-1405 low dose
Placebo	Placebo Comparator	Placebo is to be administered orally once daily for 2 weeks	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SK-1405 high dose	Drug	SK-1405 high dose is to be administered orally once daily for 2 weeks	SK-1405 high dose

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Investigational site (there may be other sites in this country)		Tokyo			Japan