Uremic Pruritus in Hemodialysis PatientsPhase 2NCT03218501
A Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus
A Phase 2 study testing SK-1405 high dose and SK-1405 low dose in people with Uremic Pruritus in Hemodialysis Patients, run by Sanwa Kagaku Kenkyusho Co., Ltd. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Uremic Pruritus in Hemodialysis Patients
- What is being tested?
- SK-1405 high dose and SK-1405 low dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 269 participants
- Where
- 1 siteJapan
- Study dates
- 28 Aug 2017to 25 May 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site
Investigational site (there may be other sites in this country)
Tokyo
About this study
Official title: A Phase II, Double-Blind, Randomized, Placebo-Controlled 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.
- Conditions
- Uremic Pruritus in Hemodialysis Patients
- Being tested
- SK-1405 high dose, SK-1405 low dose, Placebo
- Keywords
- Uremic Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SK-1405 high doseDrug
SK-1405 high dose is to be administered orally once daily for 2 weeks
SK-1405 low doseDrug
SK-1405 low dose is to be administered orally once daily for 2 weeks
PlaceboDrug
Placebo is to be administered orally once daily for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| SK-1405 high dose | Active comparator | SK-1405 high dose is to be administered orally once daily for 2 weeks Receives: Drug: SK-1405 high dose |
| SK-1405 low dose | Active comparator | SK-1405 low dose is to be administered orally once daily for 2 weeks Receives: Drug: SK-1405 low dose |
| Placebo | Placebo comparator | Placebo is to be administered orally once daily for 2 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Worst-itching Visual Analog Scale (VAS)
Measured: 2 weeks
Secondary outcomes (5)
Change from baseline in Worst-itching Visual Analog Scale (VAS)
Measured: 1 week, 3 weeks
Change from baseline in Itch Severity Assessment
Measured: 1 week, 2 weeks, 3 weeks
Change from baseline in Sleep Quality Assessment
Measured: 1 week, 2 weeks, 3 weeks
Change from baseline in 5D Itch Scale
Measured: 2 weeks
Number of Participants with Adverse Events
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start28 Aug 2017
- Primary completion25 May 2018
- Study completion25 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uremic Pruritus in Hemodialysis PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218501
- Sponsor's protocol ID
- MO1003
- Status last verified
- Nov 2018
- First submitted
- 13 Jul 2017
- Last updated
- 8 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-Blind, Randomized, Placebo-Controlled Study of SK-1405 in Hemodialysis Patients With Uremic Pruritus
- ClinicalTrials.gov ID
- NCT03218501
- Acronym / sponsor ID
- MO1003
- Conditions
- Uremic Pruritus in Hemodialysis Patients
- Keywords
- Uremic Pruritus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 25 May 2018 (actual)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SK-1405 high dose | Active comparator | Drug: SK-1405 high doseSK-1405 high dose is to be administered orally once daily for 2 weeks |
| SK-1405 low dose | Active comparator | Drug: SK-1405 low doseSK-1405 low dose is to be administered orally once daily for 2 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo is to be administered orally once daily for 2 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SK-1405 high doseSK-1405 high dose is to be administered orally once daily for 2 weeks | Drug | SK-1405 high dose |
| SK-1405 low doseSK-1405 low dose is to be administered orally once daily for 2 weeks | Drug | SK-1405 low dose |
| PlaceboPlacebo is to be administered orally once daily for 2 weeks | Drug | Placebo |
Primary outcome
Change from baseline in Worst-itching Visual Analog Scale (VAS)
Time frame: 2 weeks
5 secondary outcomes
Change from baseline in Worst-itching Visual Analog Scale (VAS)
Time frame: 1 week, 3 weeks
Change from baseline in Itch Severity Assessment
Time frame: 1 week, 2 weeks, 3 weeks
Change from baseline in Sleep Quality Assessment
Time frame: 1 week, 2 weeks, 3 weeks
Change from baseline in 5D Itch Scale
Time frame: 2 weeks
Number of Participants with Adverse Events
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SK-1405 high dose and SK-1405 low dose in people with Uremic Pruritus in Hemodialysis Patients, run by Sanwa Kagaku Kenkyusho Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Worst-itching Visual Analog Scale (VAS) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019.