Pruritus Clinical Trial
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
| Verified date | August 2020 |
| Source | Trevi Therapeutics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 167 |
| Est. completion date | January 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Southwest Georgia Nephrology Clinic PC | Albany | Georgia |
| United States | Renal Medicine Associates | Albuquerque | New Mexico |
| United States | Newtown Dialysis Center Inc | Astoria | New York |
| United States | North America Research Institute | Azusa | California |
| United States | Central Nephrology Medical Group | Bakersfield | California |
| United States | Pegasus Dialysis Center | Bakersfield | California |
| United States | Nephrology Research Consortium | Bethlehem | Pennsylvania |
| United States | Nephrology Associates PC | Birmingham | Alabama |
| United States | SouthEast Renal Research Institute | Chattanooga | Tennessee |
| United States | University of Cincinnati | Cincinnati | Ohio |
| United States | Durham Nephrology Associates | Durham | North Carolina |
| United States | Fresenius Medical Care of Evergreen Park | Evergreen Park | Illinois |
| United States | U.S. Renal Care Inc. | Fort Worth | Texas |
| United States | U.S. Renal Care, Inc. | Fort Worth | Texas |
| United States | Nephrology Center DBA Paragon Health | Kalamazoo | Michigan |
| United States | Kidney Associates of Kansas City PC | Kansas City | Missouri |
| United States | Renal Physicians of Georgia | Macon | Georgia |
| United States | U.S. Renal Care Inc | Mansfield | Texas |
| United States | McComb Limited Care Facility | McComb | Mississippi |
| United States | Pacific Renal Research Institute | Meridian | Idaho |
| United States | Nephrology and Hypertension Associates PC | Middlebury | Connecticut |
| United States | University South Alabama Medical Center | Mobile | Alabama |
| United States | Nephrology-Hypertension Associates of Central New Jersey PA | North Brunswick | New Jersey |
| United States | Pines Clinical Research | Pembroke Pines | Florida |
| United States | Delaware Valley Nephrology | Philadelphia | Pennsylvania |
| United States | Dialysis Clinic, Inc. | Philadelphia | Pennsylvania |
| United States | Arizona Kidney Disease and Hypertension Center | Phoenix | Arizona |
| United States | U.S. Renal Care Inc. | Pine Bluff | Arkansas |
| United States | Wake Nephrology Associates PA | Raleigh | North Carolina |
| United States | Western New England Renal and Transplant Association | Springfield | Massachusetts |
| United States | Carolina Diabetes and Kidney Center | Sumter | South Carolina |
| United States | Genesis Clinical Research | Tampa | Florida |
| United States | Mark Lee MD, Inc | Whittier | California |
| United States | Brookview Hills Research Associates LLC | Winston-Salem | North Carolina |
| United States | DaVita Central Orlando Dialysis | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Trevi Therapeutics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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