Chronic Kidney Disease (CKD) Clinical Trial
Official title:
The Pieda Study: A Phase 3b Investigation Of Erythropoietin Drugs Using A Specified Dosing Algorithm: A Randomized Open Label Dosing Study In Adult Chronic Kidney Disease Subjects On Hemodialysis
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.
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