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About DRIVE and DRIVE II1,2*†

Drive and Drive II

DRIVE—Dialysis Patients' Response to IV Iron With Elevated Ferritin (n=134)

Design
  • Open-label, randomized, controlled, multicenter trial conducted in 37 centers across the US
Primary objective
  • 6-week study to compare the difference between treatment groups in Hb change from baseline to week 6
Secondary objectives
  • Evaluate percentage of responders (defined as ≥ 2 g/dL increase in Hb at any point) and time to response
  • Compare the difference between two groups in change from baseline reticulocyte hemoglobin content (CHr). Change from baseline in TSAT, serum ferritin, and C-reactive protein was evaluated for addressing safety
Drive Findings

DRIVE II—Dialysis Patients' Response to IV Iron With Elevated Ferritin II (n=112)

Design
  • 6-week observational extension of DRIVE to evaluate the effects of usual clinical management (administration of epoetin and iron doses as clinically indicated)
Primary objective
  • Compare the extended effects of a 1 g course of Ferrlecit or no iron on epoetin doses
Secondary objective
  • Compare the mean change between treatment groups in Hb, TSAT, and serum ferritin from end of DRIVE to end of DRIVE II

* The DRIVE (Dialysis Patients' Response to IV Iron With Elevated Ferritin) (n=134) study was an open-label, randomized, controlled, 6-week multicenter study conducted in anemic (Hb ≤ 11 g/dL) HD patients receiving adequate epoetin therapy who had elevated SF levels (500-1200 ng/mL) and low TSAT (≤ 25%). After baseline, epoetin dosage was increased by 25% in both groups and was maintained through the course of the study. Patients were stratified by baseline serum ferritin ≤ 800 ng/mL or > 800 ng/mL and were randomly assigned 1:1 to either the Control Group (no iron, n=65) or the Ferric Gluconate Group (1 g of Ferrlecit administered in 8 consecutive 125 mg doses, n=64). The study’s predefined primary objective was to compare the change in Hb levels from baseline to week 6 between treatment groups.1

† The DRIVE II (Dialysis Patients' Response to IV Iron With Elevated Ferritin) (n=112) was a 6-week observational extension of the DRIVE study to evaluate the extended effects of a 1 g course of Ferrlecit on epoetin doses and iron indices and the effects of usual clinical management (administration of epoetin and IV iron [Ferrlecit or iron sucrose] doses as clinically indicated).1

Important Safety Information for Ferrlecit

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferrlecit (sodium ferric gluconate) in post marketing experience. Patients may present with shock, clinically significant hypotension, loss of consciousness, or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Ferrlecit administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferrlecit when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
  • Ferrlecit is contraindicated in patients with known hypersensitivity to Ferrlecit.
  • Ferrlecit may cause clinically significant hypotension. Administration of Ferrlecit may augment hypotension caused by dialysis and usually resolves within one to two hours. Monitor patients for sign and symptoms of hypotension during and following administration.
  • Do not administer to patients with evidence of iron overload.
  • Ferrlecit contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with serious adverse events and death in pediatric patients. Caution should be exercised when Ferrlecit is administered to a pregnant or nursing woman.
  • The most commonly reported adverse reactions (≥10%):
    • In adult patients were nausea, vomiting and/or diarrhea, injection site reaction, hypotension, cramps, hypertension, dizziness, dyspnea, chest pain, leg cramps and pain.
    • In patients 6 to 15 years of age the most common adverse reactions (≥10%) were hypotension, headache, hypertension, tachycardia and vomiting.

For more information on Ferrlecit, please see full Prescribing Information.

References:

1. Coyne DW, Kapoian T, Suki W, et al; the DRIVE Study Group. Ferric gluconate is highly efficacious in anemic hemodialysis patients with high serum ferritin and low transferrin saturation: results of the Dialysis Patients' Response to IV Iron with Elevated Ferritin (DRIVE) study. J Am Soc Nephrol. 2007;18:975-984.

2. Kapoian T, O'Mara NB, Singh AK, et al. Ferric gluconate reduces epoetin requirements in hemodialysis patients with elevated ferritin. J Am Soc Nephrol. 2008;19:372-379.