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

This study has been completed.
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
First received: September 13, 2005
Last updated: February 29, 2012
Last verified: February 2012
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®.

Condition Intervention Phase
Anemia, Iron-Deficiency
Kidney Failure, Chronic
Drug: Sodium Ferric Gluconate complex in sucrose
Drug: Ferrous sulfate tablets
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Open-label Study of the Safety and Efficacy of Ferrlecit® vs Oral Iron in Iron Deficient Patients With Chronic Kidney Disease Being Treated With Erythropoietic Therapy

Resource links provided by NLM:

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • Baseline Hemoglobin Concentration [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Change in Hemoglobin (Hgb) [ Time Frame: Baseline to 10 weeks ] [ Designated as safety issue: No ]
    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:
  • Baseline Serum Ferritin Concentration [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Change in Serum Ferritin [ Time Frame: Baseline to 10 weeks ] [ Designated as safety issue: No ]
    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.

Enrollment: 52
Study Start Date: April 2003
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV iron Drug: Sodium Ferric Gluconate complex in sucrose
Sodium ferric gluconate complex in sucrose, 250 mg IV weekly for 4 doses
Other Name: Ferrlecit
Active Comparator: oral iron Drug: Ferrous sulfate tablets
ferrous sulfate 325 mg three times daily for 6 weeks


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224042

  Show 24 Study Locations
Sponsors and Collaborators
Watson Pharmaceuticals
Study Director: Adel R Rizkala, PharmD, MS Watson Laboratories, Inc.
  More Information

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00224042     History of Changes
Other Study ID Numbers: FER0201 
Study First Received: September 13, 2005
Results First Received: December 23, 2009
Last Updated: February 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:
Iron deficiency
Chronic kidney disease
Erythropoietic agents
Sodium Ferric Gluconate
Anemia, Iron-Deficiency/drug therapy/etiology
Kidney Failure, Chronic/blood/complications/therapy
Erythropoietin, Recombinant/adverse effects/therapeutic use

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Urologic Diseases
Ferric Compounds
Ferric gluconate
Growth Substances
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on May 26, 2016