Back to resultsStudy of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
Primary Purpose
Uremic Pruritus, Pruritus
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
nalbuphine HCl ER tablets 60 mg BID
nalbuphine HCl ER tablets 120mg BID
Placebo tablets BID
Sponsored by
About this trial
This is an interventional treatment trial for Uremic Pruritus focused on measuring uremic, pruritus, itch, chronic itch, nalbuphine
Eligibility Criteria
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.
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, LLC
- Central Nephrology Medical Group
- Academic Medical Research Institute
- Mark Lee MD, Inc
- Nephrology and Hypertension Associates PC
- DaVita Inc Clinical Research Unit
- Nephrology Center DBA Paragon Health
- Pines Clinical Research Inc
- 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
- 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
- DaVita Northtown's Dialysis Center
- Durham Nephrology Associates
- Wake Nephrology Associates PA
- Brookview Hills Research Associates LLC
- University Of Cincinnati
- Nephrology Research Consortium
- Delaware Valley Nephrology
- Dialysis Clinic Inc.
- South Carolina Nephrology and Hypertension
- South Carolina Nephrology and Hypertension
- Carolina Diabetes and Kidney Center
- Southwest Renal Research Institute
- U.S. Renal Care Inc
- U.S Renal Care Inc.
- U.S. Renal Care Inc.
- Fresenius Medical Care Shorewood
- Norbert Barlicki University Hospital No1. of the Medical University of Lodz
- International Healthcare Systems S.A IHS Craiova Dialysis Center
- International Healthcare Systems S.A IHS Fundeni Dialysis Center
- S.C Gral Medical S.R.L
- S.C Diaverum Romania S.R.I, Industriilor Diaverum Dialysis Center
- SC Diaverum Romania SRL, Splai Dialysis Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
nalbuphine HCl ER 60mg
nalbuphine HCl ER 120mg
Sugar pill
Arm Description
nalbuphine HCl ER tablets 60 mg BID
nalbuphine HCl ER tablets 120 mg BID
Placebo tablets BID
Outcomes
Primary Outcome Measures
Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02143648
Brief Title
Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm 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
June 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (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 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.
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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
373 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nalbuphine HCl ER 60mg
Arm Type
Experimental
Arm Description
nalbuphine HCl ER tablets 60 mg BID
Arm Title
nalbuphine HCl ER 120mg
Arm Type
Experimental
Arm Description
nalbuphine HCl ER tablets 120 mg BID
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Placebo tablets BID
Intervention Type
Drug
Intervention Name(s)
nalbuphine HCl ER tablets 60 mg BID
Other Intervention Name(s)
nalbuphine ER
Intervention Description
nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks
Intervention Type
Drug
Intervention Name(s)
nalbuphine HCl ER tablets 120mg BID
Other Intervention Name(s)
nalbuphine ER
Intervention Description
nalbuphine HCl ER tablets 120mg BID administered for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo tablets BID
Other Intervention Name(s)
sugar pill
Intervention Description
Placebo tablets BID administered for 8 weeks
Primary Outcome Measure Information:
Title
Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
63317
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
76103
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, LLC
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
Academic Medical Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
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
DaVita Inc Clinical Research Unit
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Nephrology Center DBA Paragon Health
City
Miami
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Pines Clinical Research Inc
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
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
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
College Point
State/Province
New York
ZIP/Postal Code
11356
Country
United States
Facility Name
DaVita Northtown's Dialysis Center
City
Tonawanda
State/Province
New York
ZIP/Postal Code
14150
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
19129
Country
United States
Facility Name
South Carolina Nephrology and Hypertension
City
Hampton
State/Province
South Carolina
ZIP/Postal Code
29924
Country
United States
Facility Name
South Carolina Nephrology and Hypertension
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
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
Southwest 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
Facility Name
Fresenius Medical Care Shorewood
City
Shorewood
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States
Facility Name
Norbert Barlicki University Hospital No1. of the Medical University of Lodz
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
International Healthcare Systems S.A IHS Craiova Dialysis Center
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200347
Country
Romania
Facility Name
International Healthcare Systems S.A IHS Fundeni Dialysis Center
City
Bucharest
ZIP/Postal Code
022325
Country
Romania
Facility Name
S.C Gral Medical S.R.L
City
Bucharest
ZIP/Postal Code
031422
Country
Romania
Facility Name
S.C Diaverum Romania S.R.I, Industriilor Diaverum Dialysis Center
City
Bucharest
ZIP/Postal Code
032895
Country
Romania
Facility Name
SC Diaverum Romania SRL, Splai Dialysis Center
City
Bucharest
ZIP/Postal Code
060021
Country
Romania
12. IPD Sharing Statement
Citations:
PubMed Identifier
33283264
Citation
Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
Results Reference
derived
Learn more about this trial
Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
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