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

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.

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Key information

Conditions

Uremic Pruritus Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Nephrology Associates PC, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nalbuphine HCl ER

Drug

nalbuphine HCl ER

Other names: nalbuphine

Primary outcomes

Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs)

Time frame: 24 weeks

The number of participants reporting at least one TEAE of a particular body system and preferred term are reported (incidence)

Sponsors and collaborators

Lead sponsor

Trevi Therapeutics

Industry

Registry information

Official study title

An Open Label Extension Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: May 21, 2014
Registry last updated: May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed