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

Phase 2

Completed

• Conditions: Uremic Pruritus in Hemodialysis Patients
• Interventions: Drug: SK-1405 low dose; Drug: Placebo; Drug: SK-1405 high dose

• Registration Number: NCT03218501
• Lead Sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.

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 available

Study Timeline

• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-14
• Study Start: 2017-08-28
• Primary Completion: 2018-05-25
• Study Completion: 2018-05-25
• Status Verified: 2018-11
• Last Update Submitted: 2019-03-07
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 269

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SK-1405 low dose	SK-1405 low dose	SK-1405 low dose is to be administered orally once daily for 2 weeks
Placebo	Placebo	Placebo is to be administered orally once daily for 2 weeks
SK-1405 high dose	SK-1405 high dose	SK-1405 high dose is to be administered orally once daily for 2 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline in Worst-itching Visual Analog Scale (VAS)	2 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Investigational site (there may be other sites in this country); 🇯🇵 Tokyo, Japan