ClinicalTrials.gg
Sign In
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

Browse trials for

Keywords

  • Uremic Pruritus
03

In context

Pruritus

490 studies on the registry are indexed under Pruritus; 93 are open to participants now.

This study's enrollment of 269 is above the median of 60 across 422 interventional studies indexed under Pruritus.

Browse Pruritus studies →

Lead sponsor

Sanwa Kagaku Kenkyusho Co., Ltd. is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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

06

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

07

Study locations

1 site
  • Investigational site (there may be other sites in this country)
    Tokyo, Japan
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2017 to primary completion in May 2018, 8 months.

Of 37 industry-sponsored phase 2 interventional studies under Pruritus, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 21. This study's 8 months is below that.

Counting every sponsor, half of 52 studies reached it within 16 months; a quarter within 10 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 13, 2017
First posted
Jul 14, 2017
StartActual
Aug 28, 2017
Primary completionActual
May 25, 2018
CompletionActual
May 25, 2018
Last update
Mar 8, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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 ↗

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pruritus →

Other studies from this sponsor

Sanwa Kagaku Kenkyusho Co., Ltd.

Start the discussion