The objective of this study is to assess the safety and tolerability of Venofer in patients with chronic kidney disease who cannot tolerate Ferumoxytol (Feraheme) or intravenous iron containing a dextran (INFed or Dexferrum).
This is a Phase IV, multi-center, open label study that assesses the safety and tolerability of Iron Sucrose (Venofer) in subjects with CKD who require intravenous iron for the treatment of iron deficiency anemia (IDA) but cannot tolerate Ferumoxytol or Iron Dextran.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Iron Sucrose, 1000 mg cumulative dose to be administered per the US package insert.
Luitpold Pharmaceuticals, Inc.
Norristown, Pennsylvania, United States
Incidence and severity of adverse events, overall and related from Day of first iron sucrose administration through the end of the study.
Time frame: Day 0 through 30 days after the final administration of iron sucrose
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