The DRIVE Study
The Drive Study
 
 

Dialysis Patients’ Response to IV Iron with Elevated Ferritin: The DRIVE Study2

Adult anemic hemodialysis (HD) patients with elevated serum ferritin levels and low TSAT may not have adequate iron for healthy erythropoiesis despite receiving adequate EPO doses. In these patients, elevated serum ferritin may reflect the presence of inflammation and reticulo-endothelial blockade.

The DRIVE study was designed to determine whether and how HD patients with elevated serum ferritin levels, low TSAT, and persistent anemia despite adequate epoetin therapy would respond to a course of IV iron therapy.

In this study, a total of 134 HD patients with Hb ≤11.0 g/dL, elevated serum ferritin (500-1200 ng/mL), TSAT ≤25%, and epoetin doses ≥225 IU/kg/week or 22,500 IU/week were randomized to receive Ferrlecit® (sodium ferric gluconate complex in sucrose injection) as 1 gram delivered over 8 dialysis sessions or no iron. All patients received a 25% increase in epoetin dose.

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Key Findings2

  In anemic HD patients with elevated serum ferritin, low TSAT, and receiving adequate EPO doses a course of Ferrlecit® therapy in conjunction with a 25% increase in epoetin dose  significantly improved Hb and TSAT without exacerbating existing inflammation.

Ferrlecit® therapy was safe and well tolerated in this population with no treatment-related serious adverse events reported.*

The results confirm that elevated serum ferritin in this patient population is not an accurate indicator of iron status and that many of these patients may benefit from a course of IV iron therapy.

*Study was not powered for safety

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Important Safety Information3

Ferrlecit® is indicated for the treatment of iron deficiency anemia in chronic hemodialysis patients age 6 years and over receiving supplemental epoetin therapy • Ferrlecit® is contraindicated in non iron-deficient anemias, in patients hypersensitive to Ferrlecit® or its inactive components, or with evidence of iron overload • Hypersensitivity reactions have been reported with injectable iron products • Hypotension has been reported with rapid administration of IV iron • In a single-dose, placebo-controlled safety study (n=1097), the most frequent adverse events occurring after Ferrlecit® administration were hypotension, nausea, and vomiting and/or diarrhea • In multiple-dose studies (n=126), the most frequent adverse events, whether or not related to Ferrlecit® administration were nausea, vomiting and/or diarrhea, injection site pain, hypotension, cramps, hypertension, dizziness, dyspnea, and chest pain