Experience

Venofer® landmark clinical studies

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Study Design/METHODS

Study E was a randomized, open-label, multicenter study comparing patients with PDD-CKD receiving an erythropoietin and intravenous iron to patients with PDD-CKD receiving an erythropoietin alone without iron supplementation. Patients with PDD-CKD, stable erythropoietin for 8 weeks, hemoglobin ≤11.5% g/dL, TSAT ≤25% and ferritin ≤500 ng/mL were randomized to receive either no iron or Venofer® (iron sucrose) injection, USP (300 mg in 250 mL 0.9% NaCl over 1.5 hours on Day 1 and Day 15, and 400 mg in 250 mL 0.9% NaCl over 2.5 hours on Day 29). The mean age of the 75 treated patients in the Venofer/erythropoietin group was 51.9 years (range 21 to 81 years) vs 52.8 years (range 23 to 77 years) for 46 patients in the erythropoietin-alone group.

Results

Patients in the Venofer/erythropoietin group had statistically significantly greater mean change from baseline to the highest hemoglobin value (1.3 g/dL) compared to subjects who received erythropoietin alone (0.6 g/dL) (P<0.01). A greater proportion of subjects treated with Venofer/erythropoietin (59.1%) had an increase in hemoglobin of ≥1 g/dL at any time during the study compared to the subjects who received erythropoietin only (33.3%).

STUDY REFERENCE

1. Singh H, Reed J, Noble S, Cangiano JL, Van Wyck DB; United States Iron Sucrose (Venofer) Clinical Trials Group. Effect of intravenous iron sucrose in peritoneal dialysis patients who receive erythtropoiesis-stimulating agents for anemia: a randomized, controlled trial. Clin J Am Soc Nephrol. 2006;1:475-482.