Phase 4
Completed N=52
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents
Anemia, Iron-Deficiency · Kidney Failure, Chronic
Source: ClinicalTrials.gov NCT00224042 ↗
Enrolled (actual)
52
Serious AEs
11.5%
Results posted
Mar 2012
Primary outcomePrimary: Baseline Hemoglobin Concentration — 10.3; 10.4 g/dL
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®.
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 | — |
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
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. Informational only — not medical advice.