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

American Regent

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Venofer and stable erythropoietin (EPO) regimen; Drug: stable erythropoietin (EPO) regimen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00236938

1VEN02021 / 1VEN02022

Details and patient eligibility

About

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

Full description

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.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 2 patient groups

Group A

Experimental group

Description:

Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.

Treatment:

Drug: Venofer and stable erythropoietin (EPO) regimen

Group B

Active Comparator group

Description:

Stable erythropoietin (EPO) dose and no supplemental iron.

Treatment:

Drug: stable erythropoietin (EPO) regimen