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

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: Venofer and stable erythropoietin (EPO) regimen; Drug: stable erythropoietin (EPO) regimen

• Registration Number: NCT00236938
• Lead Sponsor: American Regent, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2002-07
• Primary Completion: 2004-09
• Study Completion: 2004-10
• Study First Submitted: 2005-10-10
• Study First Submitted QC: 2005-10-10
• Study First Posted: 2005-10-12
• Results First Submitted: 2009-01-14
• Results First Submitted QC: 2009-07-31
• Results First Posted: 2009-09-07
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Venofer and stable erythropoietin (EPO) regimen	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.
Group B	stable erythropoietin (EPO) regimen	Stable erythropoietin (EPO) dose and no supplemental iron.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline to the Highest Hemoglobin up to Day 71	Change from Baseline up to Day 71

Secondary Outcome Measures

Name	Time	Method
The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71	Change from Baseline up to Day 71
The Mean Change From Baseline to the Highest Ferritin up to Day 71	Change from Baseline up to Day 71
The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71	Change from Baseline up to Day 71