Conventional-treatment-resistant Pruritus in Patients Receiving HemodialysisPhase 3TRK-820NCT01513161
Efficacy and Safety Study of TRK-820 to Treat Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis
A Phase 3 study testing nalfurafine hydrochloride (TRK-820) in people with Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether nalfurafine hydrochloride is effective and safe in the treatment for conventional-treatment-resistant pruritus in patients receiving hemodialysis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis
- What is being tested?
- nalfurafine hydrochloride (TRK-820)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2008to Oct 2009
- Phase
- Phase 3
- 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
- [At the time of obtaining the consent form]
- Chronic renal failure patients who regularly receive hemodialysis three times a week and are not likely to have a serious treatment change or acute symptoms during the study period
- Patients who received both of the drug pruritus treatments in section 1 and 2 below within one year before the day of singing consent form
- Systemic therapy of more than two consecutive weeks depending on antihistamine or antiallergic drugs falling under "prescription drugs with indication of pruritus" (oral drugs, injections, etc.)
- Local therapy depending on "prescription drugs with indication of pruritus" (ointment, etc.) or a moisturizer prescribed by a doctor (topical preparation, etc.)
- Patients for whom all the conventional pruritus treatments in section (2) are not enough
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- Patients aged 20 years or older at time of signing the consent form
- [At the time of enrollment]
- Patients whose VAS scores are measured both after breakfast and dinner for five days or more of the last 7 days of the predose observation period and whose mean of whichever the higher VAS scores after breakfast or dinner is ≥50 mm
- Patients whose whichever the higher VAS score after breakfast or dinner for the last 7 days during the preliminary observation day (measured VAS score if one is missing) is more than ≥20 mm for five days or more
- Patients who are judged to have pruritus both during the day and at night for more than two days based on the Shiratori's severity criteria assessed by the subject at days of fifth and sixth hemodialysis and the day of hemodialysis after the completion of the predose observation period, and whose whichever the higher pruritis score measured during the day or at night is 3 (moderate) for two days or more
Who cannot join
- Patients with malignant tumor
- Patients with depression, schizophrenia or dementia as complications
- Patients who currently have Child-pugh class B or C hepatic cirrhosis as complications
- Patients with clinically significant hepatic or cardiovascular diseases which cannot be controlled by diet or drug therapy
- Patients who currently have the following heart diseases: life-threatening arrhythmia; unstable angina or myocardiac infarction within 6 months; PCI or CABG within 6 months; NYHA class III or IV congestive heart failure
- Patients with atopic dermatitis or chronic urticaria as complications
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- Patients who are allergic to opioid drugs
- Patients with dependence on drug or alcohol
- Patients who received phototherapy for pruritus within one month before signing the consent form
- Patients who participated in the study of TRK-820 and received the study drug or who were already enrolled in this study
- Patients who participated in other clinical studies (including the ones using artificial kidney and medical equipment), and received the study drug or treatment with clinical equipment within one month before signing the consent form
- Pregnant women, lactating women and patients of childbearing potential who do not use contraceptive methods
- Patients who cannot report VAS scores by their own for any reason at the principal investigator or study personnel's discretion
- Patients whose complications or history can impact the results of this study at the principal investigator or subinvestisator's discretion
- Other patients who are not proper to participate in this study at the principal investigator or study personnel's discretion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 14 Day, Multi-center, Randomized, Double Blinded, Placebo-controlled, Parallel Group, Fixed Dose, Phase III Clinical Trial to Assess the Efficacy and Safety of TRK-820 in Treating Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis
The purpose of this study is to determine whether nalfurafine hydrochloride is effective and safe in the treatment for conventional-treatment-resistant pruritus in patients receiving hemodialysis.
- Being tested
- nalfurafine hydrochloride (TRK-820), Placebo
- Keywords
- pruritus
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nalfurafine hydrochloride (TRK-820)Drug
Soft capsule containing 2.5ug nalfurafine hydrochloride. Start with 2.5ug of oral administraion once daily, and can be increased up to 5ug if necessary.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| TRK-820 5μg | Active comparator | Taking TRK-820 5μg(two 2.5μg capsules) by oral route once daily for 14 days Receives: Drug: nalfurafine hydrochloride (TRK-820) |
| TRK-820 2.5μg | Active comparator | Taking TRK-820 2.5μg(one 2.5μg capsule \& one placebo capsule)by oral route once daily for 14 days Receives: Drug: nalfurafine hydrochloride (TRK-820) |
| Placebo | Placebo comparator | Taking Placebo(two placebo capsule) by oral route once daily for 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pruritus degree measured by VAS(Visual Analogue Scale) score
Measured: 4 weeks (2 weeks measurement with only conventional treatment + 2 weeks measurement with conventional treatment & investigational products)
Secondary outcomes (1)
Changes in Shiratori's severity scores assessed by the subject.
Measured: 4 weeks (2 weeks measurement with only conventional treatment + 2 weeks measurement with conventional treatment & investigational products)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startApr 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Conventional-treatment-resistant Pruritus in Patients Receiving HemodialysisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Toray Industries, Inc
- Responsible party
- Sponsor
- Investigators
- Suhng Gwon Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513161
- Sponsor's protocol ID
- TRK-820_PRU_III_2007
- Acronym
- TRK-820
- Status last verified
- Jan 2012
- First submitted
- 23 Nov 2010
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
PubMed 33283264
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 14 Day, Multi-center, Randomized, Double Blinded, Placebo-controlled, Parallel Group, Fixed Dose, Phase III Clinical Trial to Assess the Efficacy and Safety of TRK-820 in Treating Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis
- ClinicalTrials.gov ID
- NCT01513161
- Acronym / sponsor ID
- TRK-820 / TRK-820_PRU_III_2007
- Keywords
- pruritus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Toray Industries, Inc
- Study start
- Apr 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 20 Jan 2012 (estimated)
- 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 determine whether nalfurafine hydrochloride is effective and safe in the treatment for conventional-treatment-resistant pruritus in patients receiving hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TRK-820 5μg | Active comparator | Drug: nalfurafine hydrochloride (TRK-820)Taking TRK-820 5μg(two 2.5μg capsules) by oral route once daily for 14 days |
| TRK-820 2.5μg | Active comparator | Drug: nalfurafine hydrochloride (TRK-820)Taking TRK-820 2.5μg(one 2.5μg capsule \& one placebo capsule)by oral route once daily for 14 days |
| Placebo | Placebo comparator | Drug: PlaceboTaking Placebo(two placebo capsule) by oral route once daily for 14 days |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- [At the time of obtaining the consent form]
- Chronic renal failure patients who regularly receive hemodialysis three times a week and are not likely to have a serious treatment change or acute symptoms during the study period
- Patients who received both of the drug pruritus treatments in section 1 and 2 below within one year before the day of singing consent form
- Patients for whom all the conventional pruritus treatments in section (2) are not enough
- Patients aged 20 years or older at time of signing the consent form
Key exclusion criteria (15 listed)
- Patients with malignant tumor
- Patients with depression, schizophrenia or dementia as complications
- Patients who currently have Child-pugh class B or C hepatic cirrhosis as complications
- Patients with clinically significant hepatic or cardiovascular diseases which cannot be controlled by diet or drug therapy
- Patients who currently have the following heart diseases: life-threatening arrhythmia; unstable angina or myocardiac infarction within 6 months; PCI or CABG within 6 months; NYHA class III or IV congestive heart failure
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 |
|---|---|---|
| nalfurafine hydrochloride (TRK-820)Soft capsule containing 2.5ug nalfurafine hydrochloride. Start with 2.5ug of oral administraion once daily, and can be increased up to 5ug if necessary. | Drug | TRK-820 2.5μg, TRK-820 5μg |
| Placebo | Drug | Placebo |
Primary outcome
Change in pruritus degree measured by VAS(Visual Analogue Scale) score
Time frame: 4 weeks (2 weeks measurement with only conventional treatment + 2 weeks measurement with conventional treatment & investigational products)
1 secondary outcome
Changes in Shiratori's severity scores assessed by the subject.
Time frame: 4 weeks (2 weeks measurement with only conventional treatment + 2 weeks measurement with conventional treatment & investigational products)
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 20 Jan 2012.
- Derived from this study: PubMed 33283264Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
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.
Suhng Gwon Kim, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nalfurafine hydrochloride (TRK-820) in people with Conventional-treatment-resistant Pruritus in Patients Receiving Hemodialysis, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
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 11 inclusion and 15 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 20 Jan 2012. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 in pruritus degree measured by VAS(Visual Analogue Scale) score (time frame: 4 weeks (2 weeks measurement with only conventional treatment + 2 weeks measurement with conventional treatment & investigational products)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01513161, which also lists 1 linked publication.
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 20 Jan 2012.