Study of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

373

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

July 31, 2015

Study Completion Date

July 31, 2015

Conditions
Uremic PruritusPruritus
Interventions
DRUG

nalbuphine HCl ER tablets 60 mg BID

nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks

DRUG

nalbuphine HCl ER tablets 120mg BID

nalbuphine HCl ER tablets 120mg BID administered for 6 weeks

DRUG

Placebo tablets BID

Placebo tablets BID administered for 8 weeks

Trial Locations (47)

11356

Newtown Dialysis Center, Inc, College Point

14150

DaVita Northtown's Dialysis Center, Tonawanda

18017

Nephrology Research Consortium, Bethlehem

19118

Delaware Valley Nephrology, Philadelphia

19129

Dialysis Clinic Inc., Philadelphia

27103

Brookview Hills Research Associates LLC, Winston-Salem

27609

Wake Nephrology Associates PA, Raleigh

27704

Durham Nephrology Associates, Durham

29118

South Carolina Nephrology and Hypertension, Orangeburg

29150

Carolina Diabetes and Kidney Center, Sumter

29924

South Carolina Nephrology and Hypertension, Hampton

31217

Renal Physicians of Georgia, Macon

31701

Southwest Georgia Nephrology Clinic PC, Albany

32789

DaVita Central Orlando Dialysis, Winter Park

33028

Pines Clinical Research Inc, Pembroke Pines

33162

Nephrology Center DBA Paragon Health, Miami

33614

Genesis Clinical Research, Tampa

35211

Nephrology Associates PC, Birmingham

37408

Southwest Renal Research Institute, Chattanooga

39648

McComb Limited Care Facility, McComb

45267

University Of Cincinnati, Cincinnati

53211

Fresenius Medical Care Shorewood, Shorewood

60805

Fresenius Medical Care of Evergreen Park, Evergreen Park

63317

University South Alabama Medical Center, Mobile

64131

Kidney Associates of Kansas City PC, Kansas City

76063

U.S. Renal Care Inc., Mansfield

76103

U.S. Renal Care Inc, Pine Bluff

76105

U.S. Renal Care Inc, Fort Worth

76164

U.S Renal Care Inc., Fort Worth

80902

Nephrology-Hypertension Associates of Central New Jersey PA, North Brunswick

83642

Pacific Renal Research Institute, Meridian

85012

Arizona Kidney Disease and Hypertension Center, Phoenix

87109

Renal Medicine Associates, Albuquerque

90022

Academic Medical Research Institute, Los Angeles

90606

Mark Lee MD, Inc, Whittier

91702

North America Research Institute, Azusa

93308

Pegasus Dialysis, LLC, Bakersfield

93309

Central Nephrology Medical Group, Bakersfield

200347

International Healthcare Systems S.A IHS Craiova Dialysis Center, Craiova

06762

Nephrology and Hypertension Associates PC, Middlebury

06902

DaVita Inc Clinical Research Unit, Stamford

01107

Western New England Renal and Transplant Association, Springfield

90-153

Norbert Barlicki University Hospital No1. of the Medical University of Lodz, Lodz

022325

International Healthcare Systems S.A IHS Fundeni Dialysis Center, Bucharest

031422

S.C Gral Medical S.R.L, Bucharest

032895

S.C Diaverum Romania S.R.I, Industriilor Diaverum Dialysis Center, Bucharest

060021

SC Diaverum Romania SRL, Splai Dialysis Center, Bucharest

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Trevi Therapeutics

INDUSTRY