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

• Status: Completed
• Trial end date: 2002-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Regent, Inc.; Luitpold Pharmaceuticals
• Treatments: Epoetin Alfa; Ferric Oxide, Saccharated; Iron

Criteria

Inclusion Criteria:

• Creatine Clearance <40 mL/min

• Average Baseline Hemoglobin < 10.5g/dL

• TSAT < 25% and Ferritin <300ng/mL

Exclusion Criteria:

• Blood Transfusion within 30days

• Uncontrolled Hypertension

• Suffering form concommitant disease of the liver

• Serious bacterial infection

• Pregnancy / lactation

• Symptomatic HIV

• Expected to under dialysis or renal transplant during study