Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents

Watson Pharmaceuticals52 enrolled

Overview

This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents, such as Procrit® and Aranesp®.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anemia, Iron-Deficiency Kidney Failure, Chronic

Interventions

Sodium Ferric Gluconate complex in sucroseDRUG

Sodium ferric gluconate complex in sucrose, 250 mg IV weekly for 4 doses

Ferrous sulfate tabletsDRUG

ferrous sulfate 325 mg three times daily for 6 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Moderate to severe anemia * Iron deficiency * Moderate to severe chronic kidney disease * Receiving therapy with erythropoietic agent Exclusion Criteria: * Receiving dialysis * Known sensitivity to Ferrlecit® or any of its components * Clinically unstable

Locations (24)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Baseline Hemoglobin Concentration

Time frame: Baseline

Change in Hemoglobin (Hgb)

Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.

Time frame: Baseline to 10 weeks

Secondary Outcomes

Baseline Serum Ferritin Concentration

Time frame: Baseline

Change in Serum Ferritin

Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.

Time frame: Baseline to 10 weeks

Data from ClinicalTrials.gov

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