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

Study Timeline

• Study First Submitted: 2014-05-17
• Study First Submitted QC: 2014-05-20
• Study First Posted: 2014-05-21
• Study Start: 2014-06
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Disposition First Submitted: 2017-05-25
• Disposition First Submitted QC: 2017-05-25
• Disposition First Posted: 2017-06-06
• Status Verified: 2020-08
• Results First Submitted: 2020-08-04
• Results First Submitted QC: 2020-08-19
• Last Update Submitted: 2020-08-19
• Results First Posted: 2020-09-07
• Last Update Posted: 2020-09-07

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

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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.

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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.

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