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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Uremic Pruritus, Pruritus

In brief

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.

Key facts

Study ID

NCT02143648

Run by

Trevi Therapeutics

People needed

373

Starts

2014-06-01

Expected to finish

2015-07-01

Last updated by the study team

2025-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Nephrology Associates PC — Birmingham, Alabama, United States
• University South Alabama Medical Center — Mobile, Alabama, United States
• Arizona Kidney Disease and Hypertension Center — Phoenix, Arizona, United States
• U.S. Renal Care Inc — Pine Bluff, Arkansas, United States
• North America Research Institute — Azusa, California, United States
• Pegasus Dialysis, LLC — Bakersfield, California, United States
• Central Nephrology Medical Group — Bakersfield, California, United States
• Academic Medical Research Institute — Los Angeles, California, United States
• Mark Lee MD, Inc — Whittier, California, United States
• Nephrology and Hypertension Associates PC — Middlebury, Connecticut, United States
• DaVita Inc Clinical Research Unit — Stamford, Connecticut, United States
• Nephrology Center DBA Paragon Health — Miami, Florida, United States
• Pines Clinical Research Inc — Pembroke Pines, Florida, United States
• Genesis Clinical Research — Tampa, Florida, 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
• Pacific Renal Research Institute — Meridian, Idaho, 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
• 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
• Newtown Dialysis Center, Inc — College Point, New York, United States

Full record on ClinicalTrials.gov

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