Objective. We aimed to demonstrate safety and efficacy of intravenous (IV) low molecular weight iron dextran (LMWID) during treatment of anemic stage 3 and 4 chronic kidney disease (CKD) patients. Methods. Efficacy data was obtained by retrospective chart review of 150 consecutively enrolled patients. Patients were assigned per protocol to oral or IV iron, with IV iron given to those with lower iron stores and/or hemoglobin. Iron and darbepoetin were administered to achieve and maintain hemoglobin at 10–12？g/dL. Efficacy endpoints were mean hemoglobin and change in iron indices approximately 30 and 60 days after enrollment. Safety data was obtained by retrospective review of reported adverse drug events (ADEs) following 1699 infusions of LMWID (0.5–1.0？g). Results. Mean hemoglobin, iron saturation, and ferritin increased significantly from baseline to 60 days in patients assigned to LMWID (hemoglobin: 11.3 versus 9.4？g/dL; iron saturation: 24% versus 12.9%; ferritin: 294.7 versus 134.7？ng/mL; all ). Iron stores and hemoglobin were maintained in the group assigned to oral iron. Of 1699 iron dextran infusions, three ADEs occurred. Conclusions. Treatment of anemia in CKD stages 3 and 4 with LMWID and darbepoetin is efficacious. The serious ADE rate was 0.06% per infusion. 1. Introduction Erythropoiesis is optimized in chronic kidney disease by treatment with iron and erythropoiesis-stimulating agents (ESAs). For end-stage renal disease patients on hemodialysis, intravenous (IV) iron is more efficacious than oral iron [1–3]. Potential advantages of IV iron include direct iron delivery to bone marrow and tissue stores, large-dose delivery, and elimination of frequent gastrointestinal side effects associated with oral iron treatment [4–8]. Among IV iron formulations, iron isomaltoside, ferric carboxymaltose, and the iron dextrans (IDs) can be administered in total dose infusion (TDI). Both ferric gluconate and iron sucrose can be safely administered as a bolus or short infusion at doses up to 250？mg and 300？mg, respectively. Higher doses of either drug as a bolus or short infusion have been associated with unpleasant vasoactive and gastrointestinal symptoms [9, 10]. However, accelerated regimens of high-dose IV iron sucrose (500？mg over 3 hours) have been demonstrated to be safe in several studies [11–13]. The safety and efficacy of ID in nondialysis chronic kidney disease (ND-CKD) is less well reported, especially for the low molecular weight iron dextran (LMWID) INFeD [14]. Imferon, Dexferrum, and INFeD are the IDs that have been used in the USA. The first
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