Chronic Renal FailurePhase 1TRK-820NCT01248650
Safety Study of TRK-820 for Patient With Hemodialysis
A Phase 1 study testing nalfurafine hydrochloride in people with Chronic Renal Failure, run by SK Chemicals Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to observe pharmacokinetics and safety of nalfurafine hydrochloride in patients receiving hemodialysis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- nalfurafine hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2008to Dec 2008
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic renal failure who receive dialysis three times a week on a regular basis and do not expect an important change in treatment nor a rapid change in conditions
- Patients aged 20 years or older
- Patients whose post-dialysis BMI measured at the nearest time before the singing day is in the range of 70 ~ 130 %
- Patients who can understand and follow instructions and participate in the study during the entire study period
- Patients who signed the informed consent form before participating in the study
Who cannot join
- Patients who have confirmed malignant tumor
- Patients with cognitive impairment including depression, schizophrenia and dementia
- Patients with hepatic cirrhosis as a complication
- Patients with drug allergy to opioids
- Patients with drug dependency or allergic disease (including skin response to UV radiation)
- Patients who participated in other study and received the investigational drug within 1 month before the signing day
Show all 32Show fewer
- Patients who participated in other TRK-820 study within 4 weeks before the signing day
- Pregnant or lactating women or premenopausal women of childbearing potential who do not conduct contraception
- Patients who received any of the following drugs within 2 weeks before Day 1
- Azole antifungal agents
- Ketoconazole
- Fluconazole
- Itraconazole
- Clotrimazole
- Macrolide antibiotics
- Erythromycin
- Midecamycin
- Josamycin
- Roxithromycin
- Clarithromycin
- Triacetyloleandomycin
- Ritonavir
- Cyclosporine
- Nifedipine
- Cimetidine
- Amiodarone
- Patients who had the following drinks and foods within 2 weeks before Day 1
- Foods and drinks containing grape fruit juice
- Food and drinks containing St. John's wort
- Patients who participated in other clinical study during the period between the singing day and hospitalization (Day 1)
- Patients who smoked and drank from three months before the signing day
- Patients who are ineligible for the clinical study for other reasons at the investigator's discretion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Investigate Pharmacokinetics and Safety of Single-Dose TRK-820 Soft Capsule in Patient With Hemodialysis
The purpose of this study is to observe pharmacokinetics and safety of nalfurafine hydrochloride in patients receiving hemodialysis.
- Conditions
- Chronic Renal Failure
- Being tested
- nalfurafine hydrochloride
- Keywords
- Safety evaluation, Pharmacokinetic analysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nalfurafine hydrochlorideDrug
| Study group | Role | What they receive |
|---|---|---|
| TRK-820 5 μg | Active comparator | Taking TRK-820 5μg(two 2.5μg soft capsules) once on the first day of hospitalization by oral route Receives: Drug: nalfurafine hydrochloride |
| TRK-820 2.5μg | Active comparator | Taking TRK-820 2.5μg(one 2.5μg soft capsule) once on the first day of hospitalization by oral route Receives: Drug: nalfurafine hydrochloride |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startDec 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- SK Chemicals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Toray Industries, Inc
- Investigators
- Wooseong Huh, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248650
- Sponsor's protocol ID
- TRK-820_HD_I_2008
- Acronym
- TRK-820
- Status last verified
- Nov 2009
- First submitted
- 23 Nov 2010
- Last updated
- 25 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Investigate Pharmacokinetics and Safety of Single-Dose TRK-820 Soft Capsule in Patient With Hemodialysis
- ClinicalTrials.gov ID
- NCT01248650
- Acronym / sponsor ID
- TRK-820 / TRK-820_HD_I_2008
- Conditions
- Chronic Renal Failure
- Keywords
- Safety evaluation, Pharmacokinetic analysis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- SK Chemicals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Toray Industries, Inc
- Study start
- Dec 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 25 Nov 2010 (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 observe pharmacokinetics and safety of nalfurafine hydrochloride in patients receiving hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRK-820 5 μg | Active comparator | Drug: nalfurafine hydrochlorideTaking TRK-820 5μg(two 2.5μg soft capsules) once on the first day of hospitalization by oral route |
| TRK-820 2.5μg | Active comparator | Drug: nalfurafine hydrochlorideTaking TRK-820 2.5μg(one 2.5μg soft capsule) once on the first day of hospitalization by oral route |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with chronic renal failure who receive dialysis three times a week on a regular basis and do not expect an important change in treatment nor a rapid change in conditions
- Patients aged 20 years or older
- Patients whose post-dialysis BMI measured at the nearest time before the singing day is in the range of 70 ~ 130 %
- Patients who can understand and follow instructions and participate in the study during the entire study period
- Patients who signed the informed consent form before participating in the study
Key exclusion criteria (32 listed)
- Patients who have confirmed malignant tumor
- Patients with cognitive impairment including depression, schizophrenia and dementia
- Patients with hepatic cirrhosis as a complication
- Patients with drug allergy to opioids
- Patients with drug dependency or allergic disease (including skin response to UV radiation)
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 | Drug | TRK-820 2.5μg, TRK-820 5 μg |
Primary outcome
Not reported in the source record.
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 25 Nov 2010.
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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.
Wooseong Huh, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing nalfurafine hydrochloride in people with Chronic Renal Failure, 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 5 inclusion and 32 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 25 Nov 2010. 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. 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.
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 25 Nov 2010.