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

Phase 4

Completed

• Conditions: Anemia, Iron-Deficiency; Kidney Failure, Chronic
• Interventions: Drug: Sodium Ferric Gluconate complex in sucrose; Drug: Ferrous sulfate tablets

• Registration Number: NCT00224042
• Lead Sponsor: Watson Pharmaceuticals

Brief Summary

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®.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Primary Completion: 2005-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Results First Submitted: 2009-12-23
• Status Verified: 2012-02
• Results First Submitted QC: 2012-02-29
• Last Update Submitted: 2012-02-29
• Results First Posted: 2012-03-29
• Last Update Posted: 2012-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV iron	Sodium Ferric Gluconate complex in sucrose	-
oral iron	Ferrous sulfate tablets	-

Primary Outcome Measures

Name	Time	Method
Baseline Hemoglobin Concentration	Baseline
Change in Hemoglobin (Hgb)	Baseline to 10 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Baseline Serum Ferritin Concentration	Baseline
Change in Serum Ferritin	Baseline to 10 weeks	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.