This is a phase 4 clinical investigation of the efficacy and safety of Ferrlecit in the maintenance of iron stores and serum hemoglobin concentration in hemodialysis patients receiving Erythropoietin.
A Multi-Center, Open-Label, Parallel Group Study of the efficacy and safety of Ferrlecit in the Maintenance of Iron Stores and Serum Hemoglobin Concentration in Hemodialysis Patients Receiving Erythropoietin. Patients with normal iron indices receive one of two doses of Ferrlecit administered weekly throughout the treatment period. Efficacy was assesses at designated timepoints throughout the study and after the last Ferrlecit dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
Unnamed facility
Hot Springs, Arkansas, United States
Unnamed facility
Orange County, California, United States
Unnamed facility
Simi Valley, California, United States
Unnamed facility
Pembroke Pines, Florida, United States
The primary objective of this study is to evaluate the efficacy of two dose levels of Ferrlecit when compared with oral iron when administered as maintenance therapy in iron-replete hemodialysis patients who are receiving Erythropoietin.
Time frame: 22 weeks
The secondary objectives of this study include comparisons between Ferrlecit treatments to oral iron regarding changes from baseline in hematological parameters, iron indices, EPO requirements and safety.
Time frame: 22 weeks
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Unnamed facility
Winston-Salem, North Carolina, United States
Unnamed facility
Canton, Ohio, United States
Unnamed facility
Columbus, Ohio, United States
Unnamed facility
Philadelphia, Pennsylvania, United States