Uremic PruritusPhase 2/3NCT02143648
Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
A Phase 2/3 study testing nalbuphine HCl ER tablets 60 mg BID and nalbuphine HCl ER tablets 120mg BID in people with Uremic Pruritus and Pruritus, run by Trevi Therapeutics at 47 sites in 3 countries.
Trial summary
The primary objectives of the study to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in hemodialysis patients with moderate to severe uremic pruritus and to evaluate the safety and tolerability in the study population. 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 tablets 60 mg BID and nalbuphine HCl ER tablets 120mg BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 373 participants
- Where
- 47 sitesin 3 countries
- Study dates
- Jun 2014to Jul 2015
- 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 has been receiving in-center hemodialysis for ≥ 3 months and are currently on a schedule of 3 times a week.
- Subject self-categorized themselves on the Patient Assessed Disease Severity Scale during Screening
- Subject meets standard of care hemodialysis efficiency guidelines during the three months prior to completing Screening
- Have demonstrated pruritus intensity on the Itch NRS during screening
- Male or female who are at least 18 years old at the time of Screening
Who cannot join
- Subject had a significant alteration in dialysis regimen during the Screening Period
- Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study.
- Subject has pruritus that is believed to be caused by a condition unrelated to end-stage renal disease
- Has had a history of substance abuse within 6 months prior to completing Screening
- Subject has a known drug allergy to opioids
- Subject is a pregnant or lactating female.
Trial locations and contacts
47 sites in 3 countries.
47 sites in 3 countries
United States41 sites
Southwest Georgia Nephrology Clinic PC
Albany, Georgia, 31701
Renal Medicine Associates
Albuquerque, New Mexico, 87109
North America Research Institute
Azusa, California, 91702
Pegasus Dialysis, LLC
Bakersfield, California, 93308
Central Nephrology Medical Group
Bakersfield, California, 93309
Nephrology Research Consortium
Bethlehem, Pennsylvania, 18017
Nephrology Associates PC
Birmingham, Alabama, 35211
Southwest Renal Research Institute
Chattanooga, Tennessee, 37408
University Of Cincinnati
Cincinnati, Ohio, 45267
Newtown Dialysis Center, Inc
College Point, New York, 11356
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
South Carolina Nephrology and Hypertension
Hampton, South Carolina, 29924
Kidney Associates of Kansas City PC
Kansas City, Missouri, 64131
Academic Medical Research Institute
Los Angeles, California, 90022
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 Center DBA Paragon Health
Miami, Florida, 33162
Nephrology and Hypertension Associates PC
Middlebury, Connecticut, 06762
University South Alabama Medical Center
Mobile, Alabama, 63317
Nephrology-Hypertension Associates of Central New Jersey PA
North Brunswick, New Jersey, 80902
South Carolina Nephrology and Hypertension
Orangeburg, South Carolina, 29118
Pines Clinical Research Inc
Pembroke Pines, Florida, 33028
Delaware Valley Nephrology
Philadelphia, Pennsylvania, 19118
Dialysis Clinic Inc.
Philadelphia, Pennsylvania, 19129
Arizona Kidney Disease and Hypertension Center
Phoenix, Arizona, 85012
U.S. Renal Care Inc
Pine Bluff, Arkansas, 76103
Wake Nephrology Associates PA
Raleigh, North Carolina, 27609
Fresenius Medical Care Shorewood
Shorewood, Wisconsin, 53211
Western New England Renal and Transplant Association
Springfield, Massachusetts, 01107
DaVita Inc Clinical Research Unit
Stamford, Connecticut, 06902
Carolina Diabetes and Kidney Center
Sumter, South Carolina, 29150
Genesis Clinical Research
Tampa, Florida, 33614
DaVita Northtown's Dialysis Center
Tonawanda, New York, 14150
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
Romania5 sites
International Healthcare Systems S.A IHS Fundeni Dialysis Center
Bucharest, 022325
S.C Gral Medical S.R.L
Bucharest, 031422
S.C Diaverum Romania S.R.I, Industriilor Diaverum Dialysis Center
Bucharest, 032895
SC Diaverum Romania SRL, Splai Dialysis Center
Bucharest, 060021
International Healthcare Systems S.A IHS Craiova Dialysis Center
Craiova, Dolj, 200347
Poland1 site
Norbert Barlicki University Hospital No1. of the Medical University of Lodz
Lodz, 90-153
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
The primary objectives of the study to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in hemodialysis patients with moderate to severe uremic pruritus and to evaluate the safety and tolerability in the study population.
- Conditions
- Uremic Pruritus, Pruritus
- Being tested
- nalbuphine HCl ER tablets 60 mg BID, nalbuphine HCl ER tablets 120mg BID, Placebo tablets BID
- 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 ER tablets 60 mg BIDDrug
Also called nalbuphine ER
nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks
nalbuphine HCl ER tablets 120mg BIDDrug
Also called nalbuphine ER
nalbuphine HCl ER tablets 120mg BID administered for 6 weeks
Placebo tablets BIDDrug
Also called sugar pill
Placebo tablets BID administered for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| nalbuphine HCl ER 60mg | Experimental | nalbuphine HCl ER tablets 60 mg BID Receives: Drug: nalbuphine HCl ER tablets 60 mg BID |
| nalbuphine HCl ER 120mg | Experimental | nalbuphine HCl ER tablets 120 mg BID Receives: Drug: nalbuphine HCl ER tablets 120mg BID |
| Sugar pill | Placebo comparator | Placebo tablets BID Receives: Drug: Placebo tablets BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale
The evaluation period was defined as the average itch score over weeks 7 and 8 following initiation of treatment. A negative change form baseline (Evaluation Period - Baseline) signified inmprovement.
Measured: 8 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 startJun 2014
- Primary completionJul 2015
- Study completionJul 2015
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 373 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
- NCT02143648
- Sponsor's protocol ID
- TR02
- Other IDs
- 2013-005625-22
- Status last verified
- May 2025
- First submitted
- 17 May 2014
- Last updated
- 21 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
- ClinicalTrials.gov ID
- NCT02143648
- Acronym / sponsor ID
- TR02
- Conditions
- Uremic Pruritus, Pruritus
- Keywords
- uremic, pruritus, itch, chronic itch, nalbuphine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Trevi TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (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 objectives of the study to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in hemodialysis patients with moderate to severe uremic pruritus and to evaluate the safety and tolerability in the study population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nalbuphine HCl ER 60mg | Experimental | Drug: nalbuphine HCl ER tablets 60 mg BIDnalbuphine HCl ER tablets 60 mg BID |
| nalbuphine HCl ER 120mg | Experimental | Drug: nalbuphine HCl ER tablets 120mg BIDnalbuphine HCl ER tablets 120 mg BID |
| Sugar pill | Placebo comparator | Drug: Placebo tablets BIDPlacebo tablets BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has been receiving in-center hemodialysis for ≥ 3 months and are currently on a schedule of 3 times a week.
- Subject self-categorized themselves on the Patient Assessed Disease Severity Scale during Screening
- Subject meets standard of care hemodialysis efficiency guidelines during the three months prior to completing Screening
- Have demonstrated pruritus intensity on the Itch NRS during screening
- Male or female who are at least 18 years old at the time of Screening
Key exclusion criteria (6 listed)
- Subject had a significant alteration in dialysis regimen during the Screening Period
- Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study.
- Subject has pruritus that is believed to be caused by a condition unrelated to end-stage renal disease
- Has had a history of substance abuse within 6 months prior to completing Screening
- Subject has a known drug allergy to opioids
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 ER tablets 60 mg BIDAlso: nalbuphine ERnalbuphine HCl ER tablets 60 mg BID administered for 6 weeks | Drug | nalbuphine HCl ER 60mg |
| nalbuphine HCl ER tablets 120mg BIDAlso: nalbuphine ERnalbuphine HCl ER tablets 120mg BID administered for 6 weeks | Drug | nalbuphine HCl ER 120mg |
| Placebo tablets BIDAlso: sugar pillPlacebo tablets BID administered for 8 weeks | Drug | Sugar pill |
Primary outcome
Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale
Time frame: 8 weeks
The evaluation period was defined as the average itch score over weeks 7 and 8 following initiation of treatment. A negative change form baseline (Evaluation Period - Baseline) signified inmprovement.
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.
- 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
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
47 sites in 3 countries: 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 tablets 60 mg BID and nalbuphine HCl ER tablets 120mg BID in people with Uremic Pruritus and Pruritus, run by Trevi Therapeutics at 47 sites in 3 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 5 inclusion and 6 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 47 sites in United States, Romania, Poland. 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 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?
Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale (time frame: 8 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 NCT02143648, 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 21 May 2025.