Clinical trial NCT02143648: Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Uremic Pruritus
Pruritus
Keywords: uremic
pruritus
itch
chronic itch
nalbuphine
Lead sponsor: Trevi Therapeutics
Sponsor class: INDUSTRY
First posted: 2014-05-21
Enrollment: 373
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Nephrology Associates PC
state: Alabama
city: Mobile
country: United States
facility: University South Alabama Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Arizona Kidney Disease and Hypertension Center
state: Arizona
city: Pine Bluff
country: United States
facility: U.S. Renal Care Inc
state: Arkansas
city: Azusa
country: United States
facility: North America Research Institute
state: California
city: Bakersfield
country: United States
facility: Pegasus Dialysis, LLC
state: California
city: Bakersfield
country: United States
facility: Central Nephrology Medical Group
state: California
city: Los Angeles
country: United States
facility: Academic Medical Research Institute
state: California
city: Whittier
country: United States
facility: Mark Lee MD, Inc
state: California
city: Middlebury
country: United States
facility: Nephrology and Hypertension Associates PC
state: Connecticut
city: Stamford
country: United States
facility: DaVita Inc Clinical Research Unit
state: Connecticut
city: Miami
country: United States
facility: Nephrology Center DBA Paragon Health
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Clinical Research Inc
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research
state: Florida
city: Winter Park
country: United States
facility: DaVita Central Orlando Dialysis
state: Florida
city: Albany
country: United States
facility: Southwest Georgia Nephrology Clinic PC
state: Georgia
city: Macon
country: United States
facility: Renal Physicians of Georgia
state: Georgia
city: Meridian
country: United States
facility: Pacific Renal Research Institute
state: Idaho
city: Evergreen Park
country: United States
facility: Fresenius Medical Care of Evergreen Park
state: Illinois
city: Springfield
country: United States
facility: Western New England Renal and Transplant Association
state: Massachusetts
city: McComb
country: United States
facility: McComb Limited Care Facility
state: Mississippi
city: Kansas City
country: United States
facility: Kidney Associates of Kansas City PC
state: Missouri
city: North Brunswick
country: United States
facility: Nephrology-Hypertension Associates of Central New Jersey PA
state: New Jersey
city: Albuquerque
country: United States
facility: Renal Medicine Associates
state: New Mexico
city: College Point
country: United States
facility: Newtown Dialysis Center, Inc
state: New York
city: Tonawanda
country: United States
facility: DaVita Northtown's Dialysis Center
state: New York
city: Durham
country: United States
facility: Durham Nephrology Associates
state: North Carolina
city: Raleigh
country: United States
facility: Wake Nephrology Associates PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Brookview Hills Research Associates LLC
state: North Carolina
city: Cincinnati
country: United States
facility: University Of Cincinnati
state: Ohio
city: Bethlehem
country: United States
facility: Nephrology Research Consortium
state: Pennsylvania
city: Philadelphia
country: United States
facility: Delaware Valley Nephrology
state: Pennsylvania
city: Philadelphia
country: United States
facility: Dialysis Clinic Inc.
state: Pennsylvania
city: Hampton
country: United States
facility: South Carolina Nephrology and Hypertension
state: South Carolina
city: Orangeburg
country: United States
facility: South Carolina Nephrology and Hypertension
state: South Carolina
city: Sumter
country: United States
facility: Carolina Diabetes and Kidney Center
state: South Carolina
city: Chattanooga
country: United States
facility: Southwest Renal Research Institute
state: Tennessee
city: Fort Worth
country: United States
facility: U.S. Renal Care Inc
state: Texas
city: Fort Worth
country: United States
facility: U.S Renal Care Inc.
state: Texas
city: Mansfield
country: United States
facility: U.S. Renal Care Inc.
state: Texas
city: Shorewood
country: United States
facility: Fresenius Medical Care Shorewood
state: Wisconsin
city: Lodz
country: Poland
facility: Norbert Barlicki University Hospital No1. of the Medical University of Lodz
city: Craiova
country: Romania
facility: International Healthcare Systems S.A IHS Craiova Dialysis Center
state: Dolj
city: Bucharest
country: Romania
facility: International Healthcare Systems S.A IHS Fundeni Dialysis Center
city: Bucharest
country: Romania
facility: S.C Gral Medical S.R.L
city: Bucharest
country: Romania
facility: S.C Diaverum Romania S.R.I, Industriilor Diaverum Dialysis Center
city: Bucharest
country: Romania
facility: SC Diaverum Romania SRL, Splai Dialysis Center
Study officials:
affiliation: Trevi Therapeutics
name: Chief Development Officer
role: STUDY_DIRECTOR
References:
citation: 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.