Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus

May 19, 2025 updated by: Trevi Therapeutics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
373

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Lodz, Poland, 90-153
        • Norbert Barlicki University Hospital No1. of the Medical University of Lodz
  • Romania
      • Bucharest, Romania, 022325
        • International Healthcare Systems S.A IHS Fundeni Dialysis Center
      • Bucharest, Romania, 031422
        • S.C Gral Medical S.R.L
      • Bucharest, Romania, 032895
        • S.C Diaverum Romania S.R.I, Industriilor Diaverum Dialysis Center
      • Bucharest, Romania, 060021
        • SC Diaverum Romania SRL, Splai Dialysis Center
    • Dolj
      • Craiova, Dolj, Romania, 200347
        • International Healthcare Systems S.A IHS Craiova Dialysis Center
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Nephrology Associates PC
      • Mobile, Alabama, United States, 63317
        • University South Alabama Medical Center
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Arizona Kidney Disease and Hypertension Center
    • Arkansas
      • Pine Bluff, Arkansas, United States, 76103
        • U.S. Renal Care Inc
    • California
      • Azusa, California, United States, 91702
        • North America Research Institute
      • Bakersfield, California, United States, 93308
        • Pegasus Dialysis, LLC
      • Bakersfield, California, United States, 93309
        • Central Nephrology Medical Group
      • Los Angeles, California, United States, 90022
        • Academic Medical Research Institute
      • Whittier, California, United States, 90606
        • Mark Lee MD, Inc
    • Connecticut
      • Middlebury, Connecticut, United States, 06762
        • Nephrology and Hypertension Associates PC
      • Stamford, Connecticut, United States, 06902
        • DaVita Inc Clinical Research Unit
    • Florida
      • Miami, Florida, United States, 33162
        • Nephrology Center DBA Paragon Health
      • Pembroke Pines, Florida, United States, 33028
        • Pines Clinical Research Inc
      • Tampa, Florida, United States, 33614
        • Genesis Clinical Research
      • Winter Park, Florida, United States, 32789
        • DaVita Central Orlando Dialysis
    • Georgia
      • Albany, Georgia, United States, 31701
        • Southwest Georgia Nephrology Clinic PC
      • Macon, Georgia, United States, 31217
        • Renal Physicians of Georgia
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Pacific Renal Research Institute
    • Illinois
      • Evergreen Park, Illinois, United States, 60805
        • Fresenius Medical Care of Evergreen Park
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Western New England Renal and Transplant Association
    • Mississippi
      • McComb, Mississippi, United States, 39648
        • McComb Limited Care Facility
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Kidney Associates of Kansas City PC
    • New Jersey
      • North Brunswick, New Jersey, United States, 80902
        • Nephrology-Hypertension Associates of Central New Jersey PA
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Renal Medicine Associates
    • New York
      • College Point, New York, United States, 11356
        • Newtown Dialysis Center, Inc
      • Tonawanda, New York, United States, 14150
        • DaVita Northtown's Dialysis Center
    • North Carolina
      • Durham, North Carolina, United States, 27704
        • Durham Nephrology Associates
      • Raleigh, North Carolina, United States, 27609
        • Wake Nephrology Associates PA
      • Winston-Salem, North Carolina, United States, 27103
        • Brookview Hills Research Associates Llc
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Nephrology Research Consortium
      • Philadelphia, Pennsylvania, United States, 19118
        • Delaware Valley Nephrology
      • Philadelphia, Pennsylvania, United States, 19129
        • Dialysis Clinic Inc.
    • South Carolina
      • Hampton, South Carolina, United States, 29924
        • South Carolina Nephrology and Hypertension
      • Orangeburg, South Carolina, United States, 29118
        • South Carolina Nephrology and Hypertension
      • Sumter, South Carolina, United States, 29150
        • Carolina Diabetes and Kidney Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37408
        • Southwest Renal Research Institute
    • Texas
      • Fort Worth, Texas, United States, 76105
        • U.S. Renal Care Inc
      • Fort Worth, Texas, United States, 76164
        • U.S Renal Care Inc.
      • Mansfield, Texas, United States, 76063
        • U.S. Renal Care Inc.
    • Wisconsin
      • Shorewood, Wisconsin, United States, 53211
        • Fresenius Medical Care Shorewood

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Sugar pill
Placebo tablets BID
Drug: Placebo tablets BID
Placebo tablets BID administered for 8 weeks
Other Names:
  • sugar pill
Experimental: nalbuphine HCl ER 60mg
nalbuphine HCl ER tablets 60 mg BID
Drug: nalbuphine HCl ER tablets 60 mg BID
nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks
Other Names:
  • nalbuphine ER
Experimental: nalbuphine HCl ER 120mg
nalbuphine HCl ER tablets 120 mg BID
Drug: nalbuphine HCl ER tablets 120mg BID
nalbuphine HCl ER tablets 120mg BID administered for 6 weeks
Other Names:
  • nalbuphine ER

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Trevi Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Chief Development Officer, Trevi Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TR02
  • 2013-005625-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings