Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
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
2 other identifiers
interventional
373
3 countries
47
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2014
Shorter than P25 for phase_2
47 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 17, 2014
CompletedFirst Posted
Study publicly available on registry
May 21, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
September 7, 2020
CompletedMay 21, 2025
May 1, 2025
1.1 years
May 17, 2014
August 4, 2020
May 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
8 weeks
Study Arms (3)
nalbuphine HCl ER 60mg
EXPERIMENTALnalbuphine HCl ER tablets 60 mg BID
nalbuphine HCl ER 120mg
EXPERIMENTALnalbuphine HCl ER tablets 120 mg BID
Sugar pill
PLACEBO COMPARATORPlacebo tablets BID
Interventions
nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks
nalbuphine HCl ER tablets 120mg BID administered for 6 weeks
Placebo tablets BID administered for 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Nephrology Associates PC
Birmingham, Alabama, 35211, United States
University South Alabama Medical Center
Mobile, Alabama, 63317, United States
Arizona Kidney Disease and Hypertension Center
Phoenix, Arizona, 85012, United States
U.S. Renal Care Inc
Pine Bluff, Arkansas, 76103, United States
North America Research Institute
Azusa, California, 91702, United States
Pegasus Dialysis, LLC
Bakersfield, California, 93308, United States
Central Nephrology Medical Group
Bakersfield, California, 93309, United States
Academic Medical Research Institute
Los Angeles, California, 90022, United States
Mark Lee MD, Inc
Whittier, California, 90606, United States
Nephrology and Hypertension Associates PC
Middlebury, Connecticut, 06762, United States
DaVita Inc Clinical Research Unit
Stamford, Connecticut, 06902, United States
Nephrology Center DBA Paragon Health
Miami, Florida, 33162, United States
Pines Clinical Research Inc
Pembroke Pines, Florida, 33028, 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
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
College Point, New York, 11356, United States
DaVita Northtown's Dialysis Center
Tonawanda, New York, 14150, 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, 19129, United States
South Carolina Nephrology and Hypertension
Hampton, South Carolina, 29924, United States
South Carolina Nephrology and Hypertension
Orangeburg, South Carolina, 29118, United States
Carolina Diabetes and Kidney Center
Sumter, South Carolina, 29150, United States
Southwest 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
Fresenius Medical Care Shorewood
Shorewood, Wisconsin, 53211, United States
Norbert Barlicki University Hospital No1. of the Medical University of Lodz
Lodz, 90-153, Poland
International Healthcare Systems S.A IHS Craiova Dialysis Center
Craiova, Dolj, 200347, Romania
International Healthcare Systems S.A IHS Fundeni Dialysis Center
Bucharest, 022325, Romania
S.C Gral Medical S.R.L
Bucharest, 031422, Romania
S.C Diaverum Romania S.R.I, Industriilor Diaverum Dialysis Center
Bucharest, 032895, Romania
SC Diaverum Romania SRL, Splai Dialysis Center
Bucharest, 060021, Romania
Related Publications (1)
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.
PMID: 33283264DERIVED
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
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2014
First Posted
May 21, 2014
Study Start
June 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
May 21, 2025
Results First Posted
September 7, 2020
Record last verified: 2025-05