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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00224055
First received: September 13, 2005
Last updated: February 29, 2012
Last verified: February 2012
History of Changes
  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 not receiving erythropoietic agents (hormones that stimulate the bone marrow to make more red blood cells).


Condition Intervention Phase
Anemia, Iron-Deficiency
Kidney Failure, Chronic
 Drug: Sodium Ferric Gluconate Complex in Sucrose Injection
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • 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:
  • 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: 89
Study Start Date: April 2003
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV iron
Sodium ferric gluconate
 Drug: Sodium Ferric Gluconate Complex in Sucrose Injection
Sodium Ferric Gluconate Complex in Sucrose Injection (Ferrlecit®), 250 mg IV weekly for 4 weeks
Active Comparator: oral iron
ferrous sulfate
 Drug: Ferrous sulfate tablets
ferrous sulfate, 325 mg oral, three times daily for 6 weeks

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224055

  Show 24 Study Locations
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Naomi Dahl, Pharm.D. Watson Laboratories, Inc.
  More Information

Publications:

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00224055     History of Changes
Other Study ID Numbers: FER0202
Study First Received: September 13, 2005
Results First Received: February 29, 2012
Last Updated: February 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:
Iron deficiency
Anemia
Chronic kidney disease
 Sodium Ferric Gluconate
Anemia, Iron-Deficiency/drug therapy/etiology
Kidney Failure, Chronic/blood/complications/therapy

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

ClinicalTrials.gov processed this record on May 19, 2013