A phase 3b study for subjects receiving Epogen to compare a dosing algorithm between Hospira Epoetin and Standard of Care Epogen.
Primary Objective: To evaluate switching from Epogen to Epoetin Hospira for maintenance of hemoglobin levels in anemic chronic kidney disease (CKD) subjects on hemodialysis using a specified algorithm for the dosing of erythropoietin stimulating agents (ESA). Secondary Objective: To evaluate switching from Epogen to Epoetin Hospira on the dosing of ESA in anemic CKD subjects on hemodialysis using a specified algorithm for the dosing of ESA. Exploratory Objectives: To generate hypotheses regarding maintenance of hemoglobin levels, dosing of ESA, intravenous (IV) iron dosing requirements, transferrin saturation (TSAT) levels and ferritin levels associated with the switch from Epogen to Epoetin Hospira in anemic CKD subjects on hemodialysis using specified algorithms for the dosing of ESA and for the dosing of IV iron, that are standard of care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
432
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: 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.
Percentage of Time When Participants Had Hemoglobin Levels Between 9 to 11 Gram Per Deciliter (g/dL)
Time frame: Week 17 up to Week 24
Change From Baseline in Weekly Mean Study Medication Dose Over Final 8 Weeks of Study Treatment
Time frame: Baseline (8 Weeks prior to randomization), Week 17 up to Week 24
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Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics.
California Institute of Renal Research
Chula Vista, California, United States
California Institute of Renal Research at Fresenius Medical Care
Poway, California, United States
Fresenius Medical Care Rancho
Rancho Bernardo, California, United States
California Institute of Renal Research at Fresenius Medical Care Kearny Mesa
San Diego, California, United States
Fresenius Medical Care Paradise Valley
San Diego, California, United States
Fresenius Medical Care
Tampa, Florida, United States
Fresenius Medical Care
Tampa, Florida, United States
Genesis Clinical Research, LLC
Tampa, Florida, United States
Frenova Renal Research
Boise, Idaho, United States
Fresenius Medical Care North America - Liberty Dialysis
Boise, Idaho, United States
...and 35 more locations