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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00224042
First Posted: September 22, 2005
Last Update Posted: March 29, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Watson Pharmaceuticals
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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 ]
  • 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 Outcome Measures:
  • Baseline Serum Ferritin Concentration [ Time Frame: Baseline ]
  • 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.


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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224042


  Show 24 Study Locations
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
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
First Submitted: September 13, 2005
First Posted: September 22, 2005
Results First Submitted: December 23, 2009
Results First Posted: March 29, 2012
Last Update Posted: March 29, 2012
Last Verified: February 2012

Keywords provided by Watson Pharmaceuticals:
Iron deficiency
Anemia
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
Kidney Diseases
Renal Insufficiency, Chronic
Anemia, Iron-Deficiency
Renal Insufficiency
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Ferric gluconate
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics