Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus
An Open Label Extension Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
2 other identifiers
interventional
167
1 country
35
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2014
Shorter than P25 for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2014
CompletedFirst Posted
Study publicly available on registry
May 21, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
September 7, 2020
CompletedMay 21, 2025
August 1, 2020
1.3 years
May 19, 2014
August 5, 2020
May 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
24 weeks
Study Arms (1)
nalbuphine HCl ER
EXPERIMENTALnalbuphine 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.
Interventions
Eligibility Criteria
You may qualify if:
- Subject completed participation in the TR02 study
- Subject is currently receiving in-center hemodialysis at the time of consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Nephrology Associates PC
Birmingham, Alabama, 35211, United States
University South Alabama Medical Center
Mobile, Alabama, 36617, United States
Arizona Kidney Disease and Hypertension Center
Phoenix, Arizona, 85012, United States
U.S. Renal Care Inc.
Pine Bluff, Arkansas, 71603, United States
North America Research Institute
Azusa, California, 91702, United States
Pegasus Dialysis Center
Bakersfield, California, 93308, United States
Central Nephrology Medical Group
Bakersfield, California, 93309, United States
Mark Lee MD, Inc
Whittier, California, 90606, United States
Nephrology and Hypertension Associates PC
Middlebury, Connecticut, 06762, United States
Pines Clinical Research
Pembroke Pines, Florida, 33025, United States
Genesis Clinical Research
Tampa, Florida, 33614, United States
DaVita Central Orlando Dialysis
Winter Park, Florida, 32789, United States
Southwest Georgia Nephrology Clinic PC
Albany, Georgia, 31701, United States
Renal Physicians of Georgia
Macon, Georgia, 31217, United States
Pacific Renal Research Institute
Meridian, Idaho, 83642, United States
Fresenius Medical Care of Evergreen Park
Evergreen Park, Illinois, 60805, United States
Western New England Renal and Transplant Association
Springfield, Massachusetts, 01107, United States
Nephrology Center DBA Paragon Health
Kalamazoo, Michigan, 49007, United States
McComb Limited Care Facility
McComb, Mississippi, 39648, United States
Kidney Associates of Kansas City PC
Kansas City, Missouri, 64131, United States
Nephrology-Hypertension Associates of Central New Jersey PA
North Brunswick, New Jersey, 80902, United States
Renal Medicine Associates
Albuquerque, New Mexico, 87109, United States
Newtown Dialysis Center Inc
Astoria, New York, 11102, United States
Durham Nephrology Associates
Durham, North Carolina, 27704, United States
Wake Nephrology Associates PA
Raleigh, North Carolina, 27609, United States
Brookview Hills Research Associates LLC
Winston-Salem, North Carolina, 27103, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Nephrology Research Consortium
Bethlehem, Pennsylvania, 18017, United States
Delaware Valley Nephrology
Philadelphia, Pennsylvania, 19118, United States
Dialysis Clinic, Inc.
Philadelphia, Pennsylvania, 19140, United States
Carolina Diabetes and Kidney Center
Sumter, South Carolina, 29150, United States
SouthEast Renal Research Institute
Chattanooga, Tennessee, 37408, United States
U.S. Renal Care, Inc.
Fort Worth, Texas, 76105, United States
U.S. Renal Care Inc.
Fort Worth, Texas, 76164, United States
U.S. Renal Care Inc
Mansfield, Texas, 76063, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Thomas Sciascia, MD
- Organization
- Trevi Therapeutics
Study Officials
- STUDY DIRECTOR
Chief Development Officer
Trevi Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2014
First Posted
May 21, 2014
Study Start
September 1, 2014
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
May 21, 2025
Results First Posted
September 7, 2020
Record last verified: 2020-08