Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus
- Registration Number
- NCT02143973
- Lead Sponsor
- Trevi Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 167
- Subject completed participation in the TR02 study
- Subject is currently receiving in-center hemodialysis at the time of consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description nalbuphine HCl ER nalbuphine HCl ER nalbuphine 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.
- Primary Outcome Measures
Name Time Method Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs) 24 weeks The number of participants reporting at least one TEAE of a particular body system and preferred term are reported (incidence)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (34)
Pegasus Dialysis Center
🇺🇸Bakersfield, California, United States
Pines Clinical Research
🇺🇸Pembroke Pines, Florida, United States
Central Nephrology Medical Group
🇺🇸Bakersfield, California, United States
University South Alabama Medical Center
🇺🇸Mobile, Alabama, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Arizona Kidney Disease and Hypertension Center
🇺🇸Phoenix, Arizona, United States
Pacific Renal Research Institute
🇺🇸Meridian, Idaho, United States
SouthEast Renal Research Institute
🇺🇸Chattanooga, Tennessee, United States
Nephrology and Hypertension Associates PC
🇺🇸Middlebury, Connecticut, United States
Genesis Clinical Research
🇺🇸Tampa, Florida, United States
Nephrology Associates PC
🇺🇸Birmingham, Alabama, United States
U.S. Renal Care Inc.
🇺🇸Fort Worth, Texas, United States
Mark Lee MD, Inc
🇺🇸Whittier, California, United States
North America Research Institute
🇺🇸Azusa, California, United States
DaVita Central Orlando Dialysis
🇺🇸Winter Park, Florida, United States
Southwest Georgia Nephrology Clinic PC
🇺🇸Albany, Georgia, United States
Renal Physicians of Georgia
🇺🇸Macon, Georgia, United States
Fresenius Medical Care of Evergreen Park
🇺🇸Evergreen Park, Illinois, United States
Western New England Renal and Transplant Association
🇺🇸Springfield, Massachusetts, United States
McComb Limited Care Facility
🇺🇸McComb, Mississippi, United States
Nephrology Center DBA Paragon Health
🇺🇸Kalamazoo, Michigan, United States
Kidney Associates of Kansas City PC
🇺🇸Kansas City, Missouri, United States
Nephrology-Hypertension Associates of Central New Jersey PA
🇺🇸North Brunswick, New Jersey, United States
Renal Medicine Associates
🇺🇸Albuquerque, New Mexico, United States
Wake Nephrology Associates PA
🇺🇸Raleigh, North Carolina, United States
Newtown Dialysis Center Inc
🇺🇸Astoria, New York, United States
Durham Nephrology Associates
🇺🇸Durham, North Carolina, United States
Brookview Hills Research Associates LLC
🇺🇸Winston-Salem, North Carolina, United States
Nephrology Research Consortium
🇺🇸Bethlehem, Pennsylvania, United States
Delaware Valley Nephrology
🇺🇸Philadelphia, Pennsylvania, United States
Dialysis Clinic, Inc.
🇺🇸Philadelphia, Pennsylvania, United States
Carolina Diabetes and Kidney Center
🇺🇸Sumter, South Carolina, United States
U.S. Renal Care Inc
🇺🇸Mansfield, Texas, United States
U.S. Renal Care, Inc.
🇺🇸Fort Worth, Texas, United States