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

Uremic Pruritus in Hemodialysis Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03218501
• Other study ID #: MO1003
• Status: Completed
• Phase: Phase 2
• Start date: August 28, 2017
• Est. completion date: May 25, 2018

Study information

• Verified date: November 2018
• Source: Sanwa Kagaku Kenkyusho Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: May 25, 2018
• Est. primary completion date: May 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pruritus
• Uremic Pruritus in Hemodialysis Patients

Intervention

Drug:
• SK-1405 high dose
SK-1405 high dose is to be administered orally once daily for 2 weeks
• SK-1405 low dose
SK-1405 low dose is to be administered orally once daily for 2 weeks
• Placebo
Placebo is to be administered orally once daily for 2 weeks

Locations

Country	Name	City	State
Japan	Investigational site (there may be other sites in this country)	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sanwa Kagaku Kenkyusho Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Worst-itching Visual Analog Scale (VAS)		2 weeks
Secondary	Change from baseline in Worst-itching Visual Analog Scale (VAS)		1 week, 3 weeks
Secondary	Change from baseline in Itch Severity Assessment		1 week, 2 weeks, 3 weeks
Secondary	Change from baseline in Sleep Quality Assessment		1 week, 2 weeks, 3 weeks
Secondary	Change from baseline in 5D Itch Scale		2 weeks
Secondary	Number of Participants with Adverse Events		5 weeks