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

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Regent, Inc.; Luitpold Pharmaceuticals
• Treatments: Epoetin Alfa; Ferric Compounds; Ferric Oxide, Saccharated; Iron

Criteria

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.