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

Trevi Therapeutics167 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

167

Conditions

Uremic Pruritus Pruritus

Interventions

nalbuphine HCl ERDRUG

nalbuphine HCl ER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (35)

Outcomes

Primary Outcomes

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

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

Time frame: 24 weeks

Data from ClinicalTrials.gov

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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 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

...and 25 more locations