Uremic PruritusPhase 2/3NCT02143973
Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus
A Phase 2/3 study testing nalbuphine HCl ER in people with Uremic Pruritus and Pruritus, run by Trevi Therapeutics at 35 sites in United States.
Trial summary
The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER tablets during a treatment period of up to 24 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uremic Pruritus, Pruritus
- What is being tested?
- nalbuphine HCl ER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 35 sitesUnited States
- Study dates
- Sep 2014to Jan 2016
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject completed participation in the TR02 study
- Subject is currently receiving in-center hemodialysis at the time of consent
Who cannot join
- Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study
- Subject received opiates on a daily basis during the 1 week prior to screening
- Other than the TR02 Study Drug, Subject received any investigational drug within 4 weeks prior to Screening
- Subject is a pregnant or lactating female
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Southwest Georgia Nephrology Clinic PC
Albany, Georgia, 31701
Renal Medicine Associates
Albuquerque, New Mexico, 87109
Newtown Dialysis Center Inc
Astoria, New York, 11102
North America Research Institute
Azusa, California, 91702
Pegasus Dialysis Center
Bakersfield, California, 93308
Central Nephrology Medical Group
Bakersfield, California, 93309
Nephrology Research Consortium
Bethlehem, Pennsylvania, 18017
Nephrology Associates PC
Birmingham, Alabama, 35211
SouthEast Renal Research Institute
Chattanooga, Tennessee, 37408
University of Cincinnati
Cincinnati, Ohio, 45267
Durham Nephrology Associates
Durham, North Carolina, 27704
Fresenius Medical Care of Evergreen Park
Evergreen Park, Illinois, 60805
U.S. Renal Care, Inc.
Fort Worth, Texas, 76105
U.S. Renal Care Inc.
Fort Worth, Texas, 76164
Nephrology Center DBA Paragon Health
Kalamazoo, Michigan, 49007
Kidney Associates of Kansas City PC
Kansas City, Missouri, 64131
Renal Physicians of Georgia
Macon, Georgia, 31217
U.S. Renal Care Inc
Mansfield, Texas, 76063
McComb Limited Care Facility
McComb, Mississippi, 39648
Pacific Renal Research Institute
Meridian, Idaho, 83642
Nephrology and Hypertension Associates PC
Middlebury, Connecticut, 06762
University South Alabama Medical Center
Mobile, Alabama, 36617
Nephrology-Hypertension Associates of Central New Jersey PA
North Brunswick, New Jersey, 80902
Pines Clinical Research
Pembroke Pines, Florida, 33025
Delaware Valley Nephrology
Philadelphia, Pennsylvania, 19118
Dialysis Clinic, Inc.
Philadelphia, Pennsylvania, 19140
Arizona Kidney Disease and Hypertension Center
Phoenix, Arizona, 85012
U.S. Renal Care Inc.
Pine Bluff, Arkansas, 71603
Wake Nephrology Associates PA
Raleigh, North Carolina, 27609
Western New England Renal and Transplant Association
Springfield, Massachusetts, 01107
Carolina Diabetes and Kidney Center
Sumter, South Carolina, 29150
Genesis Clinical Research
Tampa, Florida, 33614
Mark Lee MD, Inc
Whittier, California, 90606
Brookview Hills Research Associates LLC
Winston-Salem, North Carolina, 27103
DaVita Central Orlando Dialysis
Winter Park, Florida, 32789
About this study
Official title: An Open Label Extension Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER tablets during a treatment period of up to 24 weeks.
- Conditions
- Uremic Pruritus, Pruritus
- Being tested
- nalbuphine HCl ER
- Keywords
- Uremic, Pruritus, Itch, Chronic Itch, Nalbuphine
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nalbuphine HCl ERDrug
Also called nalbuphine
nalbuphine HCl ER
| Study group | Role | What they receive |
|---|---|---|
| nalbuphine HCl ER | Experimental | nalbuphine HCl ER titrated from a dose of 30 mg QD to 120 BID for up to 3 weeks based on tolerability and efficacy, then maintained for an additional 21 weeks. Total duration of 24 weeks. Receives: Drug: nalbuphine HCl ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs)
The number of participants reporting at least one TEAE of a particular body system and preferred term are reported (incidence)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trevi Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Development Officer, Study director, Trevi Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143973
- Sponsor's protocol ID
- TR02ext
- Other IDs
- 2013-005626-29
- Status last verified
- Aug 2020
- First submitted
- 19 May 2014
- Last updated
- 21 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Extension Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
- ClinicalTrials.gov ID
- NCT02143973
- Acronym / sponsor ID
- TR02ext
- Conditions
- Uremic Pruritus, Pruritus
- Keywords
- Uremic, Pruritus, Itch, Chronic Itch, Nalbuphine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Trevi TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 May 2014 (estimated)
- Results
- Posted 7 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER tablets during a treatment period of up to 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nalbuphine HCl ER | Experimental | Drug: nalbuphine HCl ERnalbuphine HCl ER titrated from a dose of 30 mg QD to 120 BID for up to 3 weeks based on tolerability and efficacy, then maintained for an additional 21 weeks. Total duration of 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject completed participation in the TR02 study
- Subject is currently receiving in-center hemodialysis at the time of consent
Key exclusion criteria (4 listed)
- Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study
- Subject received opiates on a daily basis during the 1 week prior to screening
- Other than the TR02 Study Drug, Subject received any investigational drug within 4 weeks prior to Screening
- Subject is a pregnant or lactating female
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 |
|---|---|---|
| nalbuphine HCl ERAlso: nalbuphinenalbuphine HCl ER | Drug | nalbuphine HCl ER |
Primary outcome
Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: 24 weeks
The number of participants reporting at least one TEAE of a particular body system and preferred term are reported (incidence)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Uremic Pruritus
Active, not recruitingObservational study
Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls
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.
Chief Development Officer study director
Trevi Therapeutics
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing nalbuphine HCl ER in people with Uremic Pruritus and Pruritus, run by Trevi Therapeutics at 35 sites in United States.
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 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: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 7 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: 24 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 21 May 2025.