NCT00236951

Intravenous (IV) Iron vs. No Iron as the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy

A Phase III Randomized Controlled Study Comparing Iron Sucrose Intravenously to No Iron Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly, fixed doses of erythropoietin in patients who had or had not responded to erythropoietin therapy alone.

Detailed description

This was a two stage, randomized, controlled study of cancer patients undergoing or planning to undergo chemotherapy. After stage one, (where patients were exposed to an erythropoiesis stimulating agent), patients were randomized to receive either IV iron sucrose or no iron supplementation. Patients were then followed to safety and efficacy endpoints.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	iron sucrose injection USP
DRUG	stable erythropoietin therapy

Timeline

• Start date: 2003-02-01
• Primary completion: 2005-10-01
• Completion: 2005-12-01
• First posted: 2005-10-12
• Last updated: 2018-02-20
• Results posted: 2009-09-23