SAFETY AND EFFICACY OF TOTAL-DOSE IRON DEXTRAN ADMINISTRATION IN PATIENTS ON HOME RENAL REPLACEMENT THERAPIES

Objective: To determine the safety and efficacy of intravenous total d ose iron (TDI) replacement in patients treated with home renal replace ment therapy. Design: Prospective open-label study on end points in th e population studied. Setting: Institutional outpatient home dialysis program. Patients: The study included 20 end-stage renal disease (ESRD ) patients, performing chronic peritoneal or home hemodialysis, with i ron deficiency defined as ferritin <100 ng/mL and/or an iron saturatio n <20%. Intervention: The total dose of iron dextran was calculated an d infused at a rate not exceeding 6 mg/min. Hemoglobin, hematocrit, ir on studies, and liver function tests (LFTs) were obtained before and 3 to 4 weeks after TDI infusion. Hematocrit of patients failing to achi eve an increase in Hct over this period was re-examined 2 to 4 weeks l ater looking for a delayed response. Main Outcome Measures: Primary en d points for efficacy were changes in Hct, ferritin, and iron saturati on. Toxicity was measured as reported immediate and delayed symptoms a nd elevated transaminases and/or alkaline phosphatase levels.Results: A median iron dose of 1000 mg (range, 325 - 1500 mg) was administered. The infusions were generally weil tolerated. Clinical adverse effects were seen in 2 patients weighing less than 50 kg. No increase in LFT results was seen. Hematocrit increased 2.2% (95% CI, 0.5% - 3.9%) from 29.0% to 31.2% (p = 0.01) within 4 weeks of infusion. Significant inc reases also occurred in iron saturation (from 13% to 22%, p = 0.001) a nd ferritin (from 234 to 305 ng/mL, p = 0.008). Among the 9 patients w ho did not respond with a significant increase in Hct, 2 had a delayed response, increasing the overall response from 63% at 4 weeks to 71%, 8 weeks after TDI. inadequate erythropoietin dosing and low-grade inf ectious/inflammatory disorders may have contributed to a poor response in several patients. Conclusion: Total dose iron is a safe and effect ive means of restoring iron and erythropoietic response in ESRD patien ts weighing more than 50 kg who receive their renal replacement therap y at home.