Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus

Phase 2

Completed

• Conditions: Pruritus; Uremic Pruritus
• Interventions: Drug: nalbuphine HCl ER

• Registration Number: NCT02143973
• Lead Sponsor: Trevi Therapeutics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-19
• Study First Posted: 2014-05-21
• Study Start: 2014-09
• Primary Completion: 2016-01
• Study Completion: 2016-01
• 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: 2020-08-05
• Results First Submitted QC: 2020-08-19
• Results First Posted: 2020-09-07
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nalbuphine HCl ER	nalbuphine HCl ER	nalbuphine HCl ER titrated from a dose of 30 mg QD to 120 BID for up to 3 weeks based on tolerability and efficacy, then maintained for an additional 21 weeks. Total duration of 24 weeks.

Primary Outcome Measures

Name	Time	Method
Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs)	24 weeks	The number of participants reporting at least one TEAE of a particular body system and preferred term are reported (incidence)

Trial Locations

Locations (34)

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 Center; 🇺🇸 Bakersfield, California, United States

Central Nephrology Medical Group; 🇺🇸 Bakersfield, California, United States

Mark Lee MD, Inc; 🇺🇸 Whittier, California, United States

Nephrology and Hypertension Associates PC; 🇺🇸 Middlebury, Connecticut, United States

Pines Clinical Research; 🇺🇸 Pembroke Pines, Florida, United States

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