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

Kidney Failure, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224055
• Other study ID #: FER0202
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: February 29, 2012
• Start date: April 2003
• Est. completion date: September 2004

Study information

• Verified date: February 2012
• Source: Watson Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: September 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Sodium Ferric Gluconate Complex in Sucrose Injection
Sodium Ferric Gluconate Complex in Sucrose Injection (Ferrlecit®), 250 mg IV weekly for 4 weeks
• Ferrous sulfate tablets
ferrous sulfate, 325 mg oral, three times daily for 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Watson Pharmaceuticals

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

Agarwal R, Rizkala AR, Bastani B, Kaskas MO, Leehey DJ, Besarab A. A randomized controlled trial of oral versus intravenous iron in chronic kidney disease. Am J Nephrol. 2006;26(5):445-54. Epub 2006 Oct 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin (Hgb)	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.	Baseline to 10 weeks	No
Secondary	Change in Serum Ferritin	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.	Baseline to 10 weeks	No