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

August 19, 2020 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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

373

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

  • 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

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
Intervention / Treatment
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

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

Trevi Therapeutics

Investigators

  • Study Director: Thomas Sciascia, MD, 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

June 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

May 17, 2014

First Submitted That Met QC Criteria

May 20, 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

  • 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.

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