Phase 4 N=52 Randomized Treatment

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

Anemia, Iron-Deficiency · Kidney Failure, Chronic

Bottom Line

View on ClinicalTrials.gov: NCT00224042 ↗

Enrolled (actual)

Serious AEs

11.5%

Results posted

Mar 2012

Primary outcome: Primary: Baseline Hemoglobin Concentration — 10.3; 10.4 g/dL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Sodium Ferric Gluconate complex in sucrose (Drug); Ferrous sulfate tablets (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Watson Pharmaceuticals
Primary completion: May 2005

Outcome Measures

Outcome	Result	p-value
PRIMARY Baseline Hemoglobin Concentration	10.3; 10.4	—
PRIMARY Change in Hemoglobin (Hgb)	1.2; 1.0	—
SECONDARY Baseline Serum Ferritin Concentration	74.3; 68.7	—
SECONDARY Change in Serum Ferritin	150.0; 18.1	—

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®.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00224042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.