DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study explores the safety and efficacy of intravenous iron therapy in anemic hemodialysis patients treated with epoetin alfa, who have higher serum ferritin levels, but low to normal transferrin saturation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Watson Pharmaceuticals
• Treatments: Ferric Compounds; Ferric gluconate

Criteria

Inclusion Criteria:

• Chronic hemodialysis

• Elevated serum ferritin with low to normal transferrin saturation (TSAT)

• Moderate to severe anemia

• Receiving epoetin alfa treatment

Exclusion Criteria:

• Known sensitivity to Ferrlecit®

• Medical conditions that would confound the efficacy evaluation

• Recent blood transfusion