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

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 Being Treated With Erythropoietic Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224042
• Other study ID #: FER0201
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: February 29, 2012
• Start date: April 2003

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 receiving erythropoietic agents, such as Procrit® and Aranesp®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. primary completion date: May 2005
• 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

• Receiving therapy with erythropoietic agent

Exclusion Criteria:

• Receiving dialysis

• Known sensitivity to Ferrlecit® or any of its components

• 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
Sodium ferric gluconate complex in sucrose, 250 mg IV weekly for 4 doses
• Ferrous sulfate tablets
ferrous sulfate 325 mg 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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Hemoglobin Concentration		Baseline	No
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	Baseline Serum Ferritin Concentration		Baseline	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