Phase 4 N=89 Randomized Treatment

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

Anemia, Iron-Deficiency · Kidney Failure, Chronic

Bottom Line

View on ClinicalTrials.gov: NCT00224055 ↗

Enrolled (actual)

Serious AEs

9.0%

Results posted

Mar 2012

Primary outcome: Primary: Change in Hemoglobin (Hgb) — 0.6; 0.2 g/dL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Sodium Ferric Gluconate Complex in Sucrose Injection (Drug); Ferrous sulfate tablets (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Watson Pharmaceuticals
Primary completion: Sep 2004

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Hemoglobin (Hgb)	0.6; 0.2	—
SECONDARY Change in Serum Ferritin	207.7; 22.6	—

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).

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00224055). 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.