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
• Results First Submitted: 2020-08-04
• Results First Submitted QC: 2020-08-19
• Results First Posted: 2020-09-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-21

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.

Trial Locations

Locations (45)

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; 🇺🇸 Fort Worth, Texas, 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

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