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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00224042
First received: September 13, 2005
Last updated: February 29, 2012
Last verified: February 2012
  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
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

  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
  • 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

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Tucson, Arizona, United States
United States, California
Los Angeles, California, United States
Palo Alto, California, United States
San Diego, California, United States
United States, Illinois
Hines, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Louisiana
Shreveport, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Springfield, Massachusetts, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New York
Bronx, New York, United States
Detroit, New York, United States
Mineola, New York, United States
New York, New York, United States
United States, North Carolina
Chapel Hill, North Carolina, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Carolina
Charlotte, South Carolina, United States
United States, Tennessee
Chattanooga, Tennessee, United States
Memphis, Tennessee, United States
United States, Texas
Houston, Texas, United States
United States, Virginia
Fairfax, Virginia, United States
Puerto Rico
San Juan, Puerto Rico
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Adel R Rizkala, PharmD, MS Watson Laboratories, Inc.
  More Information

No publications provided

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
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
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
Iron
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on October 22, 2014