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CompletedNCT03218501Updated Mar 8, 2019

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

A Phase 2 interventional study of SK-1405 high dose and SK-1405 low dose in Uremic Pruritus in Hemodialysis Patients, sponsored by Sanwa Kagaku Kenkyusho Co., Ltd.. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-03-08.

Sponsored by Sanwa Kagaku Kenkyusho Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
269
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Uremic Pruritus in Hemodialysis Patients

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Keywords

  • Uremic Pruritus
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
269 participants (actual)

Study arms

  • Active comparator
    SK-1405 high dose

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

    Drug: SK-1405 high dose

  • Active comparator
    SK-1405 low dose

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

    Drug: SK-1405 low dose

  • Placebo comparator
    Placebo

    Placebo is to be administered orally once daily for 2 weeks

    Drug: Placebo

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

05

What researchers measure

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

06

Study locations

1 site
  • Investigational site (there may be other sites in this country)
    Tokyo, Japan
07

Registry details

Key details

Study ID
NCT03218501
Lead sponsor
Sanwa Kagaku Kenkyusho Co., Ltd.
Responsible party
Sponsor
First posted
Jul 14, 2017
Start date
Aug 28, 2017
Primary completion
May 25, 2018
Completion
May 25, 2018
Last update
Mar 8, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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