drugset / Trial / NCT00236964

Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis

NCT00236964 ↗

Phase 3 Completed 96 enrolled American Regent, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study was to compare the efficacy of oral iron (ferrous sulfate) plus erythropoietin to Iron Sucrose plus erythropoietin for managing anemia patients with chronic renal failure who are not receiving dialysis.

Timeline

Start
2001-02-23
Primary completion
2002-05-30
Completion
2002-05-30

Outcome

Mixed primary results

paper There was no significant difference in hemoglobin values between IV and oral therapy. PMID 15824508 ↗

paper IV iron patients had greater increases in mean serum ferritin (288 ng/ml, p < 0.0001) compared to oral iron patients (-5.1 ng/ml, p = NS). PMID 15824508 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ferrous Sulfate Diagnostic / imaging agent 325 mg Oral
Subject Iron sucrose Unknown 200 mg Intravenous
Comparator epoetin alfa Protein / enzyme biologic 2000 iu Subcutaneous

Indications