Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia

American Regent

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Ferrous Sulfate; Drug: Venofer

Study type: Interventional

Funder types: Industry

Identifiers

NCT00236977

1VEN03027

Details and patient eligibility

About

To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.

Full description

The intent of this study was to assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure patients receiving or not receiving erythropoietin. After an extensive enrollment period, patients were randomized to receive oral iron (ferrous sulfate, 325mg three times daily (TID) for 56 days) or IV iron sucrose (total 1000mg, 500mg X 2 OR 200mg X 5 within two weeks). Erythropoietin schedule was to remain unchanged during the 56 day study.

Enrollment: 182 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hemoglobin < or = 11.5 gm/dL
• Stable dose or not receiving EPO
• Renal Anemia

Exclusion criteria

• IV iron with last 6 months
• Chronic infection, malignancy,major surgery within last month
• Blood Transfusion with last two months
• Significant blood loss within last 3 months
• Concomitant sever diseases of the liver

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

Venofer

Experimental group

Description:

iron sucrose injection

Treatment:

Drug: Venofer

Ferrous Sulfate

Active Comparator group

Description:

oral iron

Treatment:

Drug: Ferrous Sulfate