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

Watson Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Anemia, Iron-Deficiency; Kidney Failure, Chronic

Treatments: Drug: Sodium Ferric Gluconate complex in sucrose; Drug: Ferrous sulfate tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00224042

FER0201

Details and patient eligibility

About

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®.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

IV iron

Experimental group

Treatment:

Drug: Sodium Ferric Gluconate complex in sucrose

oral iron

Active Comparator group

Treatment:

Drug: Ferrous sulfate tablets