Abstract
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 P values < 0.0001). 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.
Highlights
Erythropoiesis is optimized in chronic kidney disease by treatment with iron and erythropoiesis-stimulating agents (ESAs)
This study reports the 2-month outcomes of hemoglobin (Hb), ferritin, and transferrin saturation (TSAT) in both IV and oral treatment groups from baseline
Four main iron preparations are used in the USA: two iron dextrans (LMWID, INFeD; high molecular weight iron dextrans (HMWIDs), Dexferrum), sodium ferric gluconate (Ferrlecit), iron sucrose (Venofer), and ferumoxytol (Feraheme) [23,24,25,26,27]
Summary
Erythropoiesis is optimized in chronic kidney disease by treatment with iron and erythropoiesis-stimulating agents (ESAs). 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. 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]. The first two are high molecular weight iron dextrans (HMWIDs); the last is an LMWIDs. Imferon is no longer available; it was withdrawn by the original manufacturer, Fisons, based on economic decisions [15, 16].
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