Clinical trial NCT02143973: Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus
Official title: An Open Label Extension 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: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: 24 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 Center
state: California
city: Bakersfield
country: United States
facility: Central Nephrology Medical Group
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: Pembroke Pines
country: United States
facility: Pines Clinical Research
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: Kalamazoo
country: United States
facility: Nephrology Center DBA Paragon Health
state: Michigan
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: Astoria
country: United States
facility: Newtown Dialysis Center Inc
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: Sumter
country: United States
facility: Carolina Diabetes and Kidney Center
state: South Carolina
city: Chattanooga
country: United States
facility: SouthEast 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
Study officials:
affiliation: Trevi Therapeutics
name: Chief Development Officer
role: STUDY_DIRECTOR
References: