NCT01950247

Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron

Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron and Compare the Safety, Effect on QOL and Resource Utilization, of Injectafer® vs. IV Iron Standard of Care for the Treatment of IDA in an Infusion Center

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,025 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to compare the safety, effect on quality of life, and resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also assess the ability of baseline serum hepcidin levels to predict if subjects will have a clinically meaningful hemoglobin response to oral iron therapy or to IV iron therapy.

Detailed description

The main objective of this study is to compare the safety, effect on quality of life, and resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also assess the ability of baseline serum hepcidin levels to predict if subjects will have a clinically meaningful hemoglobin response to oral iron therapy for 28 days or to IV iron therapy.

Conditions

• Iron Deficiency Anemia (IDA)

Interventions

Type	Name	Description
DRUG	Injectafer	2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg.
DRUG	SOC

Timeline

• Start date: 2013-08-15
• Primary completion: 2015-05-20
• Completion: 2015-06-01
• First posted: 2013-09-25
• Last updated: 2025-05-22
• Results posted: 2025-05-22