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Phase 4 Completed N=89 Randomized Treatment

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

Anemia, Iron-Deficiency · Kidney Failure, Chronic
Source: ClinicalTrials.gov NCT00224055 ↗
Enrolled (actual)
89
Serious AEs
9.0%
Results posted
Mar 2012
Primary outcomePrimary: Change in Hemoglobin (Hgb) — 0.6; 0.2 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 not receiving erythropoietic agents (hormones that stimulate the bone marrow to make more red blood cells).

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Hemoglobin (Hgb)
0.6; 0.2
SECONDARY
Change in Serum Ferritin
207.7; 22.6

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. Informational only — not medical advice.

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