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

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

Full Title of Study: “A Randomized, Controlled, Open-label Study of the Safety and Efficacy of Ferrlecit® vs Oral Iron in Iron Deficient Patients With Chronic Kidney Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2004

Interventions

  • Drug: Sodium Ferric Gluconate Complex in Sucrose Injection
    • Sodium Ferric Gluconate Complex in Sucrose Injection (Ferrlecit®), 250 mg IV weekly for 4 weeks
  • Drug: Ferrous sulfate tablets
    • ferrous sulfate, 325 mg oral, three times daily for 6 weeks

Arms, Groups and Cohorts

  • Experimental: IV iron
    • Sodium ferric gluconate
  • Active Comparator: oral iron
    • ferrous sulfate

Clinical Trial Outcome Measures

Primary Measures

  • Change in Hemoglobin (Hgb)
    • Time Frame: 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 Measures

  • Change in Serum Ferritin
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Watson Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Naomi Dahl, Pharm.D., Study Director, Watson Laboratories, Inc.

Citations Reporting on Results

Agarwal R, Rizkala AR, Bastani B, Kaskas MO, Leehey DJ, Besarab A. A randomized controlled trial of oral versus intravenous iron in chronic kidney disease. Am J Nephrol. 2006;26(5):445-54. Epub 2006 Oct 11.

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