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

Primary Purpose

Uremic Pruritus, Pruritus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
nalbuphine HCl ER
Sponsored by
Trevi Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uremic Pruritus focused on measuring Uremic, Pruritus, Itch, Chronic Itch, Nalbuphine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nephrology Associates PC
  • University South Alabama Medical Center
  • Arizona Kidney Disease and Hypertension Center
  • U.S. Renal Care Inc.
  • North America Research Institute
  • Pegasus Dialysis Center
  • Central Nephrology Medical Group
  • Mark Lee MD, Inc
  • Nephrology and Hypertension Associates PC
  • Pines Clinical Research
  • Genesis Clinical Research
  • DaVita Central Orlando Dialysis
  • Southwest Georgia Nephrology Clinic PC
  • Renal Physicians of Georgia
  • Pacific Renal Research Institute
  • Fresenius Medical Care of Evergreen Park
  • Western New England Renal and Transplant Association
  • Nephrology Center DBA Paragon Health
  • McComb Limited Care Facility
  • Kidney Associates of Kansas City PC
  • Nephrology-Hypertension Associates of Central New Jersey PA
  • Renal Medicine Associates
  • Newtown Dialysis Center Inc
  • Durham Nephrology Associates
  • Wake Nephrology Associates PA
  • Brookview Hills Research Associates LLC
  • University of Cincinnati
  • Nephrology Research Consortium
  • Delaware Valley Nephrology
  • Dialysis Clinic, Inc.
  • Carolina Diabetes and Kidney Center
  • SouthEast Renal Research Institute
  • U.S. Renal Care, Inc.
  • U.S. Renal Care Inc.
  • U.S. Renal Care Inc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

nalbuphine HCl ER

Arm Description

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
May 19, 2014
Last Updated
August 19, 2020
Sponsor
Trevi Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02143973
Brief Title
Open Label Extension Study of Nalbuphine HCl ER in Hemodialysis Patients With Uremic Pruritus
Official Title
An Open Label Extension Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trevi Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremic Pruritus, Pruritus
Keywords
Uremic, Pruritus, Itch, Chronic Itch, Nalbuphine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nalbuphine HCl ER
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
nalbuphine HCl ER
Other Intervention Name(s)
nalbuphine
Intervention Description
nalbuphine HCl ER
Primary Outcome Measure Information:
Title
Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs)
Description
The number of participants reporting at least one TEAE of a particular body system and preferred term are reported (incidence)
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Sciascia, MD
Organizational Affiliation
Trevi Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Nephrology Associates PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
University South Alabama Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Arizona Kidney Disease and Hypertension Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
U.S. Renal Care Inc.
City
Pine Bluff
State/Province
Arkansas
ZIP/Postal Code
71603
Country
United States
Facility Name
North America Research Institute
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
Pegasus Dialysis Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93308
Country
United States
Facility Name
Central Nephrology Medical Group
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Mark Lee MD, Inc
City
Whittier
State/Province
California
ZIP/Postal Code
90606
Country
United States
Facility Name
Nephrology and Hypertension Associates PC
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
Facility Name
Pines Clinical Research
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33025
Country
United States
Facility Name
Genesis Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
DaVita Central Orlando Dialysis
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Southwest Georgia Nephrology Clinic PC
City
Albany
State/Province
Georgia
ZIP/Postal Code
31701
Country
United States
Facility Name
Renal Physicians of Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Pacific Renal Research Institute
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Fresenius Medical Care of Evergreen Park
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Facility Name
Western New England Renal and Transplant Association
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Nephrology Center DBA Paragon Health
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
McComb Limited Care Facility
City
McComb
State/Province
Mississippi
ZIP/Postal Code
39648
Country
United States
Facility Name
Kidney Associates of Kansas City PC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Nephrology-Hypertension Associates of Central New Jersey PA
City
North Brunswick
State/Province
New Jersey
ZIP/Postal Code
80902
Country
United States
Facility Name
Renal Medicine Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Newtown Dialysis Center Inc
City
Astoria
State/Province
New York
ZIP/Postal Code
11102
Country
United States
Facility Name
Durham Nephrology Associates
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Wake Nephrology Associates PA
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Brookview Hills Research Associates LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Nephrology Research Consortium
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Delaware Valley Nephrology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19118
Country
United States
Facility Name
Dialysis Clinic, Inc.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Carolina Diabetes and Kidney Center
City
Sumter
State/Province
South Carolina
ZIP/Postal Code
29150
Country
United States
Facility Name
SouthEast Renal Research Institute
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37408
Country
United States
Facility Name
U.S. Renal Care, Inc.
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76105
Country
United States
Facility Name
U.S. Renal Care Inc.
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76164
Country
United States
Facility Name
U.S. Renal Care Inc
City
Mansfield
State/Province
Texas
ZIP/Postal Code
76063
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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