Experience

Venofer® landmark clinical studies

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Study Design/METHODS

Study D was a randomized, open-label, multicenter, active-controlled study of the safety and efficacy of oral iron versus Venofer® (iron sucrose) injection, USP in patients with NDD-CKD with or without erythropoietin therapy. Erythropoietin therapy was stable for 8 weeks prior to randomization. In the study, 188 patients with NDD-CKD, hemoglobin ≤11.0 g/dL, transferrin saturation ≤25% and ferritin ≤300 ng/mL were randomized to receive oral iron (325 mg ferrous sulfate 3 times daily for 56 days) or Venofer (either 200 mg over 2 to 5 minutes 5 times within 14 days or two 500 mg infusions on Day 1 and Day 14, administered over 3.5 to 4 hours). The mean age of the 91 treated patients in the Venofer group was 61.6 years (range 25 to 86 years) and 64 years (range 21 to 86 years) for the 91 patients in the oral iron group.

Results

A statistically significantly greater proportion of Venofer subjects (35/79; 44.3%) compared to oral iron subjects (23/82; 28%) had an increase in hemoglobin ≥1 g/dL at any time during the study (P=0.03).

STUDY REFERENCE

1. Van Wyck DB, Roppolo M, Martinez CO, Mazey RM, McMurray S; United States Iron Sucrose (Venofer) Clinical Trials Group. A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD. Kidney Int. 2005;68(6):2846-2856.