Study Protocol | Baseline Demographics
The Drive Study
 
 

The intent-to-treat population consisted of 129 patients (patients who had at least 1 post-baseline Hb measurement).

Parameter (mean) Epoetin
icrease only
(n = 65)
Epoetin increase
+ Ferriecit®
(n = 64)
Hb(g/dL) 10.2 10.4
TSAT (%) 19.0 18.2
SF (ng/mL) 765 759
CHr (pg/cell) 31.0 31.4
CRP(mg/L) 25.5 29.3
Epoetin dose (IU/wk) 35.128 33.498

Hb = hemoglobin; TSAT = transferrin saturation; SF = serum ferritin; CHr = reticulocyte hemoglobin content; CRP = C-reactive protein


+ REFERENCES



 

Key Findings2

  Mean TSAT at baseline was below the target level recommended by the KDOQI guidelines.

  Mean CHr at baseline was above the target recommended by the KDOQI guidelines (>29 pg/cell).

  ~79% of patients had abnormally high CRP levels at baseline(normal CRP is <5 mg/L), indicating presence of inflammation.5

 
 
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