Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa

PHASE3CompletedINTERVENTIONAL
Enrollment

435

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

May 31, 2014

Study Completion Date

March 31, 2015

Conditions
AnemiaChronic Kidney Disease (CKD)
Interventions
DRUG

HX575 epoetin alfa

Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL.

DRUG

US-licensed epoetin alfa

Solution for subcutaneous injection.

Trial Locations (52)

11365

New York Hospital Queens, Fresh Meadows

18017

Northeast Clinical Research Centers, Inc., Bethlehem

19118

Delaware Valley Nephrology and Hypertension Associates, PC, Philadelphia

20874

Germantown Dialysis, Germantown

22304

Mendez Center For Clinical Research, LLC, Alexandria

26506

West Virginia University Hospitals and Clinic, Morgantown

27804

Boice-Willis Clinic, PA, Rocky Mount

28207

Metrolina Nephrology Associates, PA, Charlotte

28401

Southeastern Dialysis Center, Wilmington

29118

Palmetto Nephrology PA, Orangeburg

SC Nephrology & Hypertension Center, Inc., Orangeburg

30458

Atekha Nephrology Clinic LLC, Statesboro

33020

Pines Clinical Research Inc., Hollywood

33071

South Florida Nephrology, Coral Springs

33614

Genesis Clinical Research Corporation, Tampa

37923

Knoxville Kidney Center PLLC, Knoxville

42003

Four Rivers Clinical Research, Incorporated, Paducah

63640

Fresenius Management Services, Inc., Farmington

68131

Creighton University, Omaha

71101

Northwest Louisana Nephrology, Shreveport

77030

Nephrology, P.A., Houston

77074

Clinical Trial Network, Houston

78539

Gamma Clinical Research Institute, Edinburg

78756

Research Management, Inc., Austin

84770

Southern Utah Kidney and Hypertension Center, St. George

85284

Southwestern Kidney Institute, Tempe

87109

Renal Medicine Associates, Albuquerque

89106

Kidney Specialists of Southern Nevada, Las Vegas

90022

Academic Medical Research Institute, Los Angeles

90025

Ronald Reagan Medical Center, Department of Pharmaceutical Services, Drug Information Center, Los Angeles

90048

Tower Nephrology Medical Group, Los Angeles

90057

St Vincent Dialysis Center, Los Angeles

90262

Kidney Research Center, Lynwood

90301

Angel Kidney Care of Inglewood Dialysis Center, Inglewood

90603

American Institute of Research, Whittier

91324

Valley Renal Medical Group, Northridge

91344

Renal Consultants Medical Group, Granada Hills

91702

North America Research Institute, Azusa

91762

Ontario Dialysis, Inc., Ontario

91773

North America Research Institute, San Dimas

91910

California Institute of Renal Research, Chula Vista

91942

California Institute of Renal Research, La Mesa

92111

California Institute of Renal Research, San Diego

92154

La Jolla Clinical Research, Inc., San Diego

92505

Apex Research of Riverside, Riverside

92653

Alliance Research Centers, Laguna Hills

93308

Pegasus Dialysis, LLC, Bakersfield

93309

Central Nephrology Medical Group, Bakersfield

95825

Capital Nephrology Medical Group, Sacramento

03801

Seacoast Kidney and Hypertension Specialist, PLLC, Portsmouth

02903

Rhode Island Hospital, Providence

78215-2035

Renal Associates, PA, San Antonio

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sandoz

INDUSTRY