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

Watson Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Hemodialysis; Anemia, Iron-Deficiency; Kidney Failure, Chronic

Treatments: Drug: Sodium ferric gluconate,

Study type: Interventional

Funder types: Industry

Identifiers

NCT00224081

FER0401

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Ferric gluconate

Experimental group

Treatment:

Drug: Sodium ferric gluconate,

standard of care

No Intervention group