Study Protocol | Study Description
The Drive Study
 
 

Study Design:

Open-label, randomized, 6-week multicenter study

Study Population:

Adult chronic HD patients (≥90 days) with:
Elevated serum ferritin levels (500-1200 ng/mL)
Low TSAT (≤25%)
Persistent anemia despite adequate epoetin doses (Hb ≤11 g/dL while receiving epoetin doses of ≥225 IU/kg/week or ≥22,500 IU/week)
<125 mg IV iron per week during the 4 weeks prior to screening/baseline

Study Treatment:

Patients were randomly assigned to receive a course of Ferrlecit® therapy (125 mg x 8 HD sessions for a total of 1 g) and a 25% increase in epoetin dose, or a 25% increase in epoetin dose alone.
Patients were stratified by baseline ferritin level into 2 strata: SF ≤800 ng/mL (500-800 ng/mL) vs SF >800 ng/mL (801-1200 ng/mL).
No further epoetin dosage increases occurred during the study.
Administration of maintenance IV iron was prohibited.


Baseline Demographics Next

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Study Endpoints2

  Mean change in Hb from baseline to Week 6 (primary endpoint)

  Proportion of responders
(patients achieving an increase of ≥2.0 g/dL in Hb at any point in the study)

  Time to response (Hb increase of ≥2.0 g/dL)

  Mean change from baseline in TSAT, serum ferritin, reticulocyte hemoglobin content (CHr), and CRP

 
 
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