Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis

Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis

This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.

This is an open-label, prospective study comparing IV iron supplementation to standard care in anemic patients undergoing peritoneal dialysis. After successfully completing a 6 month enrollment period, qualifying patients were randomized to receive 1000mg of IV iron over a four week period, or no iron supplementation. Erythropoietin regimen was to remain stable. Patients were followed to day 71 for safety and efficacy.

Inclusion Criteria:

• Hemoglobin >= 9.5 and <= 11.5 g/dL.
• Ferritin <= 500 ng/ml.
• Serum Transferrin Saturation (TSAT) <= 25%.
• Stable erythropoietin (EPO) Regimen for 8 weeks.
• No iron for last 4 weeks before randomization.

Exclusion Criteria:

• Known Sensitivity to Iron Sucrose.
• Suffering concomitant severe diseases of the liver & cardiovascular system.
• Pregnancy / Lactation.
• Inadequate dialysis.
• Current treatment for asthma.
• Significant blood loss.
• Probability of need for transfusion or transfusion within 1 week of enrollment.
• Anticipated major surgery.
• Hemochromatosis / hemosiderosis.