Improved anemia without the need for ESA

Mircescu G, Gârneata L, Capusa C, Ursea N. Intravenous iron supplementation for the treatment of anaemia in pre-dialyzed chronic renal failure patients. Nephrol Dial Transplant. 2006;21:120-124

Background:
A longitudinal open-label, single arm, prospective study to evaluate the effects of 1-year IV iron supplementation in pre-dialysis chronic renal failure (CRF) patients without absolute iron deficiency and not receiving concomitant erythropoiesis stimulating agent (ESA) treatment.

Sixty non-diabetic CRF patients, with stable blood pressure and stable renal function 1 month prior to the study (mean glomerular filtration rate, GFR, calculated using the Cockroft-Gault formula), with Hb < 11 g/dL and stable hematologic and iron status 1 month prior to inclusion, and without any concomitant erythropoietin treatment or previous iron therapy were enrolled.

Therapeutic intervention consisted of monthly IV administration of 200 mg of Venofer® (iron sucrose, USP) administered in 500 mL saline solution over 2 hours/per 100 mg during a period of 12 months for a total dose of 2400 mg.

Measures:

  • Parameters of erythropoietic response (Hb, hematocrit) were primary measures
  • Iron status, renal function, and blood pressure were designated as secondary parameters

Results:

  • Venofer® supplementation was associated with a significant increase in Hb (from 9.7±1.1 at the baseline to 11.3±2.5 g/dL after 12 months, a mean increase of 1.6 g/dL) (P< 0.05)
  • After 12 months of Venofer® administration and without any ESA, 55% of patients reached the recommended target Hb (11 g/dL)
  • There were significant increases in iron status (serum ferritin, transferrin saturation)
  • No worsening of renal function, no increase in blood pressure and no other side effects were observed



aStatistically significant vs baseline (P< 0.05).

Conclusions:

  • Hb, serum ferritin, and TSAT levels were significantly increased
  • Venofer® is an effective and safe treatment for anemia in pre-dialysis CRF patients, avoiding the need for erythropoietin or blood transfusions


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IMPORTANT SAFETY INFORMATION:

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Venofer® (iron sucrose injection, USP). Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. If hypersensitivity reactions or signs of intolerance occur during administration, stop Venofer® immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Venofer® administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Venofer® when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.

Venofer® may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Venofer®. Hypotension following administration of Venofer® may be related to rate of administration and total dose delivered.

Venofer® is contraindicated in patients with known hypersensitivity to Venofer®. Do not administer to patients with evidence of iron overload.

In efficacy studies in non-dialysis dependent-CKD patients (N=139), the most frequent adverse events (≥5%) whether or not related to Venofer® administration, were nausea (8.6%), taste disturbance

(7.9%), peripheral edema (7.2%), diarrhea (7.2%), dizziness (6.5%), hypertension (6.5%), infusion site pain or burning (5.8%), dyspnea (5.8%), and vomiting (5.0%).

In multi-dose efficacy studies in HDD-CKD patients (N=231), the most frequent adverse events (> 5%) whether or not related to Venofer® administration, were hypotension (39.4%), muscle cramps (29.4%), nausea (14.7%), headache (12.6%), graft complications (9.5%), vomiting (9.1%), dizziness (6.5%) hypertension (6.5%), chest pain (6.1%), and diarrhea (5.2%). In the study of PDD-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer®, reported by ≥5% of these patients were infections and infestations (nasopharyngitis, sinusitis, upper respiratory tract, pharyngitis) (16.0%), diarrhea (8.0%), vomiting (8.0%), hypertension (8.0%), peripheral edema (5.3%), and nausea (5.3%).


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