Safety and Tolerability of 200mg and 100mg of Venofer Administered to Hemodialysis(HD) Patients

- Males or females over 18 years of age and able to give informed consent.

- Undergoing hemodialysis.

- If receiving epoetin α, then the dose was stable.

- Percentage serum transferrin saturation (TSAT) <50% and serum ferritin <800 ng/mL.

- Absence of infection, malignancy, or surgery in the month prior to study start.

- Intolerance of other iron products did not preclude participation in this study.

- Known sensitivity to any component of Venofer®.

- Suffering from concomitant severe diseases of the liver, cardiovascular system, severe psychiatric disorders or other conditions which, in the opinion of the investigator, made participation unacceptable.

- Serious bacterial, viral infection, or other acute infectious illness (e.g., hepatitis) unless completely resolved at least 4 weeks prior to inclusion in the study.

- Pregnancy or lactation.

- HIV positive by medical history or laboratory test (optional), or active hepatitis.

- Anemia caused by diseases (including systemic lupus erythematosus (SLE), rheumatoid arthritis, myeloma, or hereditary hemoglobinopathies) other than chronic renal failure or iron deficiency.

- Asthma.

- Clinical evidence of gastrointestinal bleeding.

- Would probably require blood transfusion or might undergo a renal transplant during the study.

- Anticipated surgery of any kind during the study other than vascular access surgery.

- Received an investigational drug within 30 days prior to screening.

- Previously participated in another Venofer® study.