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

Watson Pharmaceuticals

Status and phase: Completed; Phase 4

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

Treatments: Drug: Ferrous sulfate tablets; Drug: Sodium Ferric Gluconate Complex in Sucrose Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00224055

FER0202

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 not receiving erythropoietic agents (hormones that stimulate the bone marrow to make more red blood cells).

Enrollment: 89 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

Exclusion criteria

• Receiving dialysis
• Known sensitivity to Ferrlecit® or any of its components
• Receiving therapy with erythropoietic agent
• Clinically unstable

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

IV iron

Experimental group

Description:

Sodium ferric gluconate

Treatment:

Drug: Sodium Ferric Gluconate Complex in Sucrose Injection

oral iron

Active Comparator group

Description:

ferrous sulfate

Treatment:

Drug: Ferrous sulfate tablets