NCT00236938

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	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.
DRUG	stable erythropoietin (EPO) regimen	Stable erythropoietin (EPO) dose and no supplemental iron.

Timeline

• Start date: 2002-07-01
• Primary completion: 2004-09-01
• Completion: 2004-10-01
• First posted: 2005-10-12
• Last updated: 2021-05-19
• Results posted: 2009-09-07