Efficacy and safety of iron sucrose for iron deficiency in patients with dialysis-associated anemia: North American clinical trial

Iron sucrose has been used to provide intravenous (IV) iron therapy to pati ents outside the United States for more than 50 years. In a multicenter Nor th American clinical trial, we determined the efficacy and safety of iron s ucrose therapy in patients with dialysis-associated anemia, evidence of iro n deficiency, and below-target hemoglobin (Hgb) levels despite epoetin ther apy. Evidence of iron deficiency included a transferrin saturation (Tsat) l ess than 20% and ferritin level less than 300 ng/mL, and below-target Hgb l evels included values less than 11.0 g/dL. We administered iron sucrose in 10 doses, each administered undiluted as 100 mg IV push over 5 minutes, wit hout a prior test dose. We assessed efficacy by determining the subsequent change in Hgb, Tsat, and ferritin values. We assessed safety by recording b lood pressure and adverse events after iron sucrose injection and comparing results with those for the same patients during an observation control per iod. Results showed a significant increase in Hgb level that was first evid ent after three doses of iron sucrose and persisted at least 5 weeks after the 10th dose. Tsat and ferritin levels also increased significantly and re mained elevated. In 77 enrolled patients, including those with previous iro n dextran sensitivity, other drug allergies, or concurrent angiotensin-conv erting enzyme inhibitor use, we saw no serious adverse drug reactions and n o change in intradialytic blood pressure associated with iron sucrose admin istration. We conclude that iron sucrose injection administered as 1,000 mg in 10 divided doses by IV push without a prior test dose is safe and effec tive for the treatment of iron deficiency in patients with dialysis-associa ted anemia. (C) 2001 by the National Kidney Foundation, Inc.