Skip to main content
OpenTrials
Completed

NCT Number: NCT03218501

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Uremic Pruritus in Hemodialysis Patients

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational site (there may be other sites in this country)

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SK-1405 high dose

Drug

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

SK-1405 low dose

Drug

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

Placebo

Drug

Placebo is to be administered orally once daily for 2 weeks

Primary outcomes

  1. Change from baseline in Worst-itching Visual Analog Scale (VAS)

    Time frame: 2 weeks

Secondary outcomes

  1. Change from baseline in Worst-itching Visual Analog Scale (VAS)

    Time frame: 1 week, 3 weeks

  2. Change from baseline in Itch Severity Assessment

    Time frame: 1 week, 2 weeks, 3 weeks

  3. Change from baseline in Sleep Quality Assessment

    Time frame: 1 week, 2 weeks, 3 weeks

  4. Change from baseline in 5D Itch Scale

    Time frame: 2 weeks

  5. Number of Participants with Adverse Events

    Time frame: 5 weeks

Sponsors and collaborators

Lead sponsor

Sanwa Kagaku Kenkyusho Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 14, 2017
Registry last updated
Mar 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.