Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus

August 19, 2020 updated by: Trevi Therapeutics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • 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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Nephrology Associates PC
      • Mobile, Alabama, United States, 36617
        • University South Alabama Medical Center
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Arizona Kidney Disease and Hypertension Center
    • Arkansas
      • Pine Bluff, Arkansas, United States, 71603
        • U.S. Renal Care Inc.
    • California
      • Azusa, California, United States, 91702
        • North America Research Institute
      • Bakersfield, California, United States, 93309
        • Central Nephrology Medical Group
      • Bakersfield, California, United States, 93308
        • Pegasus Dialysis Center
      • Whittier, California, United States, 90606
        • Mark Lee MD, Inc
    • Connecticut
      • Middlebury, Connecticut, United States, 06762
        • Nephrology and Hypertension Associates PC
    • Florida
      • Pembroke Pines, Florida, United States, 33025
        • Pines Clinical Research
      • 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
    • Michigan
      • Kalamazoo, Michigan, United States, 49007
        • Nephrology Center DBA Paragon Health
    • 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
      • Astoria, New York, United States, 11102
        • Newtown Dialysis Center Inc
    • 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, 19140
        • Dialysis Clinic, Inc.
    • South Carolina
      • Sumter, South Carolina, United States, 29150
        • Carolina Diabetes and Kidney Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37408
        • Southeast 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

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject completed participation in the TR02 study
  • Subject is currently receiving in-center hemodialysis at the time of consent

Exclusion Criteria:

  • 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nalbuphine HCl ER
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.
Drug: nalbuphine HCl ER
nalbuphine HCl ER
Other Names:
  • nalbuphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 weeks

Collaborators and Investigators

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

Sponsor

Trevi Therapeutics

Investigators

  • Study Director: Thomas Sciascia, MD, Trevi Therapeutics

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

September 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 19, 2014

First Submitted That Met QC Criteria

May 19, 2014

First Posted (Estimate)

May 21, 2014

Study Record Updates

Last Update Posted (Actual)

September 7, 2020

Last Update Submitted That Met QC Criteria

August 19, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TR02ext
  • 2013-005626-29 (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.

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