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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
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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
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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
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