Uremic PruritusPhase 3AC120-8231NCT00793156
A Randomized-Withdrawal Phase 3 Study Evaluating the Safety and Efficacy of Oral Nalfurafine HCl (AC-820)in Subjects on Hemodialysis With Uremic Pruritus (Renal Itch)
A Phase 3 study testing Nalfurafine HCl 2.5 µg and Nalfurafine HCl 5.0 µg in people with Uremic Pruritus, run by Acologix, Inc..
Trial summary
Primary objective of this multicenter, double-blind, placebo controlled, randomized withdrawal study are to determine the effectiveness and safety of orally administered AC-820 in doses of 2.5 µg and 5.0 µg daily in patients with moderate to severe itching associated with end-stage renal disease and hemodialysis, and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Uremic Pruritus
- What is being tested?
- Nalfurafine HCl 2.5 µg and Nalfurafine HCl 5.0 µg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Mar 2011
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 yrs old or older
- moderate to severe pruritus
- end stage renal disease
- 3x weekly hemodialysis
Who cannot join
- pruritus not due to renal disease
- abnormal liver function
- Ca-P > 80 mg/dl or HgB <8.5 g/dl or PTH > pg/mL
- Within four months spKt/V < 1.05
About this study
Official title: A Randomized-Withdrawal Phase 3 Study Evaluation the Safety and Efficacy of Oral Nalfurafine HCl (AC-820)in Subjects on Hemodialysis With Uremic Pruritus (Renal Itch)
Primary objective of this multicenter, double-blind, placebo controlled, randomized withdrawal study are to determine the effectiveness and safety of orally administered AC-820 in doses of 2.5 µg and 5.0 µg daily in patients with moderate to severe itching associated with end-stage renal disease and hemodialysis, and perform a population PK analysis.
- Conditions
- Uremic Pruritus
- Being tested
- Nalfurafine HCl 2.5 µg, Nalfurafine HCl 5.0 µg, Placebo
- Keywords
- uremic pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalfurafine HCl 2.5 µgDrug
Daily dose of 2.5 µg
Nalfurafine HCl 5.0 µgDrug
Daily dose of 5.0 µg
PlaceboOther
Placebo daily dose
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients will be randomized into Placebo group Receives: Other: Placebo |
| 2 | Active comparator | 2.5 µg group randomized Receives: Drug: Nalfurafine HCl 2.5 µg |
| 3 | Active comparator | 5.0 µg group randomized Receives: Drug: Nalfurafine HCl 5.0 µg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy endpoint is the change in worst itching intensity from baseline, compared to that in the last two weeks of the double blind, placebo controlled, randomized withdrawal period.
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startDec 2009
- Primary completionDec 2010 (estimated)
- Study completionMar 2011 (estimated)
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acologix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793156
- Sponsor's protocol ID
- AC120-8231
- Acronym
- AC120-8231
- Status last verified
- Feb 2010
- First submitted
- 17 Nov 2008
- Last updated
- 4 Feb 2010
- 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 4 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized-Withdrawal Phase 3 Study Evaluation the Safety and Efficacy of Oral Nalfurafine HCl (AC-820)in Subjects on Hemodialysis With Uremic Pruritus (Renal Itch)
- ClinicalTrials.gov ID
- NCT00793156
- Acronym / sponsor ID
- AC120-8231 / AC120-8231
- Conditions
- Uremic Pruritus
- Keywords
- uremic pruritus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Acologix, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 19 Nov 2008 (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.
Primary objective of this multicenter, double-blind, placebo controlled, randomized withdrawal study are to determine the effectiveness and safety of orally administered AC-820 in doses of 2.5 µg and 5.0 µg daily in patients with moderate to severe itching associated with end-stage renal disease and hemodialysis, and perform a population PK analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPatients will be randomized into Placebo group |
| 2 | Active comparator | Drug: Nalfurafine HCl 2.5 µg2.5 µg group randomized |
| 3 | Active comparator | Drug: Nalfurafine HCl 5.0 µg5.0 µg group randomized |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 yrs old or older
- moderate to severe pruritus
- end stage renal disease
- 3x weekly hemodialysis
Key exclusion criteria (4 listed)
- pruritus not due to renal disease
- abnormal liver function
- Ca-P > 80 mg/dl or HgB <8.5 g/dl or PTH > pg/mL
- Within four months spKt/V < 1.05
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 HCl 2.5 µgDaily dose of 2.5 µg | Drug | 2 |
| Nalfurafine HCl 5.0 µgDaily dose of 5.0 µg | Drug | 3 |
| PlaceboPlacebo daily dose | Other | Placebo |
Primary outcome
Primary efficacy endpoint is the change in worst itching intensity from baseline, compared to that in the last two weeks of the double blind, placebo controlled, randomized withdrawal period.
Time frame: 11 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2010.
- 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.
Related trials for Uremic Pruritus
Active, not recruitingObservational study
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End-Stage Kidney Disease (ESKD), Hemodialysis
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nalfurafine HCl 2.5 µg and Nalfurafine HCl 5.0 µg in people with Uremic Pruritus, run by Acologix, Inc..
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Primary efficacy endpoint is the change in worst itching intensity from baseline, compared to that in the last two weeks of the double blind, placebo controlled, randomized withdrawal period. (time frame: 11 weeks). 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 NCT00793156, 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 4 Feb 2010.