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

September 13, 2005
February 29, 2012
April 2003
May 2005   (final data collection date for primary outcome measure)
  • 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.
Change in Hgb
Complete list of historical versions of study NCT00224042 on ClinicalTrials.gov Archive Site
  • 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.
Change in iron indices, change in quality of life
Not Provided
Not Provided
 
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents
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

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®.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Anemia, Iron-Deficiency
  • Kidney Failure, Chronic
  • Drug: Sodium Ferric Gluconate complex in sucrose
    Sodium ferric gluconate complex in sucrose, 250 mg IV weekly for 4 doses
    Other Name: Ferrlecit
  • Drug: Ferrous sulfate tablets
    ferrous sulfate 325 mg three times daily for 6 weeks
  • Experimental: IV iron
    Intervention: Drug: Sodium Ferric Gluconate complex in sucrose
  • Active Comparator: oral iron
    Intervention: Drug: Ferrous sulfate tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
Not Provided
May 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00224042
FER0201
Not Provided
Watson Pharmaceuticals
Watson Pharmaceuticals
Not Provided
Study Director: Adel R Rizkala, PharmD, MS Watson Laboratories, Inc.
Watson Pharmaceuticals
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP