432
Participants
Start Date
July 13, 2015
Primary Completion Date
July 2, 2016
Study Completion Date
July 16, 2016
Epoetin Hospira Arm
Epoetin Hospira Arm: Epoetin Hospira will be administered intravenously (IV) per the analogous version of the Fresenius Medical Care North America (FMCNA) cMAB 1 (inclusive of version 1.0, 1.1,...)erythropoietin stimulating agents (ESA) dosing algorithm for Epoetin Hospira for 24 weeks. Subjects will have Epoetin Hospira initiated using the same ESA dose level and frequency of administration for Epogen prior to randomization into the trial. Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics.
Standard of Care Arm
Standard of care arm: No interventions will be performed in this arm for the clinical study; and subjects will receive ongoing standard of care, which includes Epogen administered IV per the FMCNA cMAB 5 (inclusive of versions 5.0, 5.1,....) ESA dosing algorithm and IV iron per the FMCNA protocol that is standard of care, at FMCNA clinics during the contemporaneous 24 week period.
IV Iron
Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics.
Delaware Valley Nephrology and Hypertension Associates, PC, Philadelphia
Fresenius Medical Care- Lansdale Dialysis, Lansdale
Briggs Avenue Dialysis Center, Durham
Durham Nephrology Associates, Durham
FMC Matthews, Matthews
FMC Charlotte, Charlotte
Metrolina Nephrology Associates, PA, Charlotte
Fresenius Medical Care, Tampa
Fresenius Medical Care, Tampa
Genesis Clinical Research, LLC, Tampa
Fresenius Medical Care-Franklin, Franklin
Nephrology Associates, PC, Nashville
Knoxville Kidney Center, PLLC, Knoxville
Fresenius Dialysis West, Knoxville
Fresenius Crossville Dialysis Unit, Crossville
North Gulfport, Gulfport
South Mississippi Kidney Center, Gulfport
Fresenius Medical Care, Biloxi Dialysis Unit, Biloxi
Fresenius Medical Care-Kalamazoo East, Kalamazoo
Paragon Health PC DBA Nephrology Center, Kalamazoo
Fresenius Medical Care-Oshtemo, Kalamazoo
Mission Bend Dialysis (FMC#3971), Houston
Southwest Houston Research, Ltd., Houston
Rosenberg Dialysis (FMC#1197), Rosenberg
Gamma Medical Research Inc, McAllen
Fresenius Medical Care Weslaco, Weslaco
Fresenius Medical Care - Austin North 4478, Austin
Research Management Inc, Austin
Frenova Renal Research, Caldwell
Fresenius Medical Care North America - Liberty Dialysis, Caldwell
Frenova Renal Research, Meridian
Fresenius Medical Care North America - Liberty Dialysis, Meridian
Frenova Renal Research, Nampa
Fresenius Medical Care North America - Liberty Dialysis, Nampa
Frenova Renal Research, Boise
Fresenius Medical Care North America - Liberty Dialysis, Boise
California Institute of Renal Research, Chula Vista
California Institute of Renal Research at Fresenius Medical Care, Poway
California Institute of Renal Research at Fresenius Medical Care Kearny Mesa, San Diego
Fresenius Medical Care Rancho, Rancho Bernardo
Fresenius Medical Care Paradise Valley, San Diego
Fresenius Medical Care, Warwick
Fresenius Medical Care Carolina, Carolina
Fresenius Medical Care, Humacao
Fresenius Medical Care San Juan, San Juan
Lead Sponsor
Hospira, now a wholly owned subsidiary of Pfizer
INDUSTRY
Pfizer
INDUSTRY