Uremic PruritusPhase 1NCT03002233
TRK-820 Study in Subjects on Hemodialysis With or Without Uremic Pruritus
A Phase 1 study testing TRK-820 in people with Uremic Pruritus, run by Toray Industries, Inc at 2 sites in 2 countries.
Trial summary
This study is a 2-part study. Part A is a single-dose, open-label study design to determine the PK, safety and tolerability of 5 μg TRK-820 oral administration in subjects with end-stage renal disease (ESRD) who require hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uremic Pruritus
- What is being tested?
- TRK-820
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2016to Jul 2017
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult non-smoking male and female subjects (≥ 18 years of age) who have ESRD requiring hemodialysis, at least 3 times a week.
- Subjects has a clinical diagnosis of UP, which is uncontrolled by current medications or treatments.(Part B only)
Who cannot join
- Subject has a known hypersensitivity to opioids or the ingredients of the study medication.
- Subject has pruritus other than related to ESRD (i.e., UP).(Part B only)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Phase 1 Study to Observe Safety and Tolerability of Single and Multiple Doses of TRK-820 in Subjects on Hemodialysis and to Observe the Effect on Uremic Pruritus
This study is a 2-part study.
Part A is a single-dose, open-label study design to determine the PK, safety and tolerability of 5 μg TRK-820 oral administration in subjects with end-stage renal disease (ESRD) who require hemodialysis.
Part B is a multiple dose, open-label study design to determine the PK, PD, safety and tolerability of multiple doses in subjects with ESRD who require hemodialysis with refractory uremic pruritus (UP). Each subject will receive 3 doses of TRK-820 (2.5, 5 and 10 μg).
- Conditions
- Uremic Pruritus
- Being tested
- TRK-820
- Keywords
- TRK-820, Hemodialysis, Uremic Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRK-820Drug
Also called Nalfurafine Hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| TRK-820 | Experimental | PartA: 5 μg PartB: 2.5-10 μg Receives: Drug: TRK-820 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters: area under the time curve from time zero to 24 hours postdose(AUC0-24h)
Measured: Part A; predose to 24 hours postdose, Part B; predose to 24 hours postdose each dose
Pharmacokinetic parameters: area under the time curve from time zero to the last quantifiable concentration(AUC0-last)
Measured: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: area under the time curve from time zero extrapolated to infinity(AUC0-inf)
Measured: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: maximum observed plasma concentration (Cmax)
Measured: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: time to maximum plasma concentration(Tmax)
Measured: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: apparent elimination half-life in plasma(t½)
Measured: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: plasma concentration at 24 hours postdose(C24h)
Measured: Part A; 24 hours postdose, Part B; 24 hours postdose each dose
Pharmacokinetic parameters: apparent total clearance(CL/F)
Measured: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: terminal elimination rate(λz)
Measured: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: apparent distribution volume(Vz/F)
Measured: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: mean residence time(MRT)
Measured: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacodynamic parameters: Visual Analogue Scale (VAS) reduction from baseline
Measured: Part B only; Baseline to week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uremic PruritusStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toray Industries, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002233
- Sponsor's protocol ID
- EU820UPC01
- Status last verified
- Jul 2017
- First submitted
- 13 Dec 2016
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Observe Safety and Tolerability of Single and Multiple Doses of TRK-820 in Subjects on Hemodialysis and to Observe the Effect on Uremic Pruritus
- ClinicalTrials.gov ID
- NCT03002233
- Acronym / sponsor ID
- EU820UPC01
- Conditions
- Uremic Pruritus
- Keywords
- TRK-820, Hemodialysis, Uremic Pruritus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Toray Industries, IncIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 23 Dec 2016 (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.
This study is a 2-part study.
Part A is a single-dose, open-label study design to determine the PK, safety and tolerability of 5 μg TRK-820 oral administration in subjects with end-stage renal disease (ESRD) who require hemodialysis.
Part B is a multiple dose, open-label study design to determine the PK, PD, safety and tolerability of multiple doses in subjects with ESRD who require hemodialysis with refractory uremic pruritus (UP). Each subject will receive 3 doses of TRK-820 (2.5, 5 and 10 μg).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRK-820 | Experimental | Drug: TRK-820PartA: 5 μg PartB: 2.5-10 μg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult non-smoking male and female subjects (≥ 18 years of age) who have ESRD requiring hemodialysis, at least 3 times a week.
- Subjects has a clinical diagnosis of UP, which is uncontrolled by current medications or treatments.(Part B only)
Key exclusion criteria (2 listed)
- Subject has a known hypersensitivity to opioids or the ingredients of the study medication.
- Subject has pruritus other than related to ESRD (i.e., UP).(Part B only)
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 |
|---|---|---|
| TRK-820Also: Nalfurafine Hydrochloride | Drug | TRK-820 |
Primary outcome
Pharmacokinetic parameters: area under the time curve from time zero to 24 hours postdose(AUC0-24h)
Time frame: Part A; predose to 24 hours postdose, Part B; predose to 24 hours postdose each dose
Pharmacokinetic parameters: area under the time curve from time zero to the last quantifiable concentration(AUC0-last)
Time frame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: area under the time curve from time zero extrapolated to infinity(AUC0-inf)
Time frame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: maximum observed plasma concentration (Cmax)
Time frame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: time to maximum plasma concentration(Tmax)
Time frame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: apparent elimination half-life in plasma(t½)
Time frame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: plasma concentration at 24 hours postdose(C24h)
Time frame: Part A; 24 hours postdose, Part B; 24 hours postdose each dose
Pharmacokinetic parameters: apparent total clearance(CL/F)
Time frame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: terminal elimination rate(λz)
Time frame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: apparent distribution volume(Vz/F)
Time frame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacokinetic parameters: mean residence time(MRT)
Time frame: Part A; predose to 60 hours postdose, Part B; predose to 48 hours postdose each dose
Pharmacodynamic parameters: Visual Analogue Scale (VAS) reduction from baseline
Time frame: Part B only; Baseline to week 5
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 21 Jul 2017.
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Active, not recruitingObservational study
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRK-820 in people with Uremic Pruritus, run by Toray Industries, Inc at 2 sites in 2 countries.
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 2 inclusion and 2 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 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bulgaria, Germany. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pharmacokinetic parameters: area under the time curve from time zero to 24 hours postdose(AUC0-24h) (time frame: Part A; predose to 24 hours postdose, Part B; predose to 24 hours postdose each dose). The study lists 12 primary outcomes in all. 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 21 Jul 2017.