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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03218501

Enrollment

269

Registered

2017-07-14

Start date

2017-08-28

Completion date

2018-05-25

Last updated

2019-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uremic Pruritus in Hemodialysis Patients

Keywords

Uremic Pruritus

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.

Interventions

DRUGSK-1405 high dose

SK-1405 high dose is to be administered orally once daily for 2 weeks

DRUGSK-1405 low dose

SK-1405 low dose is to be administered orally once daily for 2 weeks

DRUGPlacebo

Placebo is to be administered orally once daily for 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	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
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026