Experience

Venofer® landmark clinical studies

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Study Design

Study B was a multicenter, open-label study of Venofer® (iron sucrose) injection, USP in 23 patients with iron deficiency and HDD-CKD who had been discontinued from iron dextran due to intolerance. Eligibility criteria were otherwise identical to Study A. The mean age of the patients in this study was 53 years, with ages ranging from 21 to 79 years. Of the 23 patients enrolled in the study, 10 (44%) were male and 13 (56%) were female. All 23 enrolled patients were evaluated for efficacy.

Results

Increases in mean hemoglobin (1.1 ± 0.2 g/dL), hematocrit (3.6% ± 0.6%), serum ferritin (266.3 ± 30.3 ng/mL) and transferrin saturation (8.7% ± 2.0%) were observed from baseline to end of treatment.

STUDY REFERENCE

1. Van Wyck DB, Cavalla G, Spinowitz BS, et al. Safety and efficacy of iron sucrose in patients sensitive to iron dextran: North American clinical trial. Am J Kidney Dis. 2000;36:88-97.