Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus

Phase 2

Completed

Conditions: Uremic Pruritus
Pruritus

Interventions: Drug: nalbuphine HCl ER tablets 60 mg BID
Drug: nalbuphine HCl ER tablets 120mg BID
Drug: Placebo tablets BID

Registration Number: NCT02143648

Lead Sponsor: Trevi Therapeutics

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 373

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nalbuphine HCl ER 60mg	nalbuphine HCl ER tablets 60 mg BID	nalbuphine HCl ER tablets 60 mg BID
nalbuphine HCl ER 120mg	nalbuphine HCl ER tablets 120mg BID	nalbuphine HCl ER tablets 120 mg BID
Sugar pill	Placebo tablets BID	Placebo tablets BID

Primary Outcome Measures

Name	Time	Method
Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale	8 weeks	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (45): North America Research Institute
🇺🇸
Azusa, California, United States
Southwest Renal Research Institute
🇺🇸
Chattanooga, Tennessee, United States
Fresenius Medical Care of Evergreen Park
🇺🇸
Evergreen Park, Illinois, United States
Western New England Renal and Transplant Association
🇺🇸
Springfield, Massachusetts, United States
Pines Clinical Research Inc
🇺🇸
Pembroke Pines, Florida, United States
Wake Nephrology Associates PA
🇺🇸
Raleigh, North Carolina, United States
Nephrology Associates PC
🇺🇸
Birmingham, Alabama, United States
Pegasus Dialysis, LLC
🇺🇸
Bakersfield, California, United States
Mark Lee MD, Inc
🇺🇸
Whittier, California, United States
DaVita Inc Clinical Research Unit
🇺🇸
Stamford, Connecticut, United States
DaVita Central Orlando Dialysis
🇺🇸
Winter Park, Florida, United States
Nephrology and Hypertension Associates PC
🇺🇸
Middlebury, Connecticut, United States
U.S. Renal Care Inc
🇺🇸
Fort Worth, Texas, United States
McComb Limited Care Facility
🇺🇸
McComb, Mississippi, United States
Norbert Barlicki University Hospital No1. of the Medical University of Lodz
🇵🇱
Lodz, Poland
Newtown Dialysis Center, Inc
🇺🇸
College Point, New York, United States
U.S. Renal Care Inc.
🇺🇸
Mansfield, Texas, United States
Dialysis Clinic Inc.
🇺🇸
Philadelphia, Pennsylvania, United States
DaVita Northtown's Dialysis Center
🇺🇸
Tonawanda, New York, United States
S.C Diaverum Romania S.R.I, Industriilor Diaverum Dialysis Center
🇷🇴
Bucharest, Romania
Academic Medical Research Institute
🇺🇸
Los Angeles, California, United States
SC Diaverum Romania SRL, Splai Dialysis Center
🇷🇴
Bucharest, Romania
Arizona Kidney Disease and Hypertension Center
🇺🇸
Phoenix, Arizona, United States
Nephrology Center DBA Paragon Health
🇺🇸
Miami, Florida, United States
Durham Nephrology Associates
🇺🇸
Durham, North Carolina, United States
University Of Cincinnati
🇺🇸
Cincinnati, Ohio, United States
University South Alabama Medical Center
🇺🇸
Mobile, Alabama, United States
Brookview Hills Research Associates LLC
🇺🇸
Winston-Salem, North Carolina, United States
Renal Physicians of Georgia
🇺🇸
Macon, Georgia, United States
Southwest Georgia Nephrology Clinic PC
🇺🇸
Albany, Georgia, 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
S.C Gral Medical S.R.L
🇷🇴
Bucharest, Romania
International Healthcare Systems S.A IHS Craiova Dialysis Center
🇷🇴
Craiova, Dolj, Romania
International Healthcare Systems S.A IHS Fundeni Dialysis Center
🇷🇴
Bucharest, Romania
Central Nephrology Medical Group
🇺🇸
Bakersfield, California, United States
Renal Medicine Associates
🇺🇸
Albuquerque, New Mexico, United States
Nephrology Research Consortium
🇺🇸
Bethlehem, Pennsylvania, United States
U.S Renal Care Inc.
🇺🇸
Fort Worth, Texas, United States
Fresenius Medical Care Shorewood
🇺🇸
Shorewood, Wisconsin, United States
Delaware Valley Nephrology
🇺🇸
Philadelphia, Pennsylvania, United States
Pacific Renal Research Institute
🇺🇸
Meridian, Idaho, United States
South Carolina Nephrology and Hypertension
🇺🇸
Orangeburg, South Carolina, United States
Genesis Clinical Research
🇺🇸
Tampa, Florida, United States
Carolina Diabetes and Kidney Center
🇺🇸
Sumter, South Carolina, United States