Experience

Venofer® landmark clinical studies

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Study Design/METHODS

Study C was a multicenter, open-label study in patients with HDD-CKD. This study enrolled patients with hemoglobin ≤10 g/dL, serum transferrin saturation ≤20% and serum ferritin ≤200 ng/mL who were undergoing maintenance hemodialysis 2 to 3 times weekly. The mean age of the patients enrolled in this study was 41 years, with ages ranging from 16 to 70 years. Of 130 patients evaluated for efficacy in this study, 68 (52%) were male and 62 (48%) were female. Forty-eight percent of the patients had previously been treated with oral iron. Exclusion criteria were similar to those in Studies A and B. Venofer® (iron sucrose) injection, USP was administered in doses of 100 mg during sequential dialysis sessions until a predetermined (calculated) total dose of iron was administered. A 50 mg dose (2.5 mL) was given to patients within 2 weeks of study entry as a test dose. Twenty-seven patients (20%) were receiving erythropoietin treatment at study entry, and they continued to receive the same erythropoietin dose for the duration of the study.

Results

The modified intention-to-treat (mITT) population consisted of 131 patients. Increases from baseline in mean hemoglobin (1.7 g/dL), hematocrit (5%), serum ferritin (434.6 ng/mL) and serum transferrin saturation (14%) were observed at Week 2 of the observation period, and these values remained increased at Week 4 of the observation period.

STUDY REFERENCE

1. Venofer® [package insert]. Shirley, NY: American Regent, Inc.; 2018.