Although
iron therapy is essential to optimize use of
erythropoiesis-stimulating agents (ESA), randomized, controlled trials have heretofore been unavailable to evaluate reliably the efficacy of intravenous
iron as an adjuvant to ESA treatment in
peritoneal dialysis (PD) patients. In a multicenter trial, patients who had
anemia, PD-dependent
chronic kidney disease, stable ESA
therapy, and a broad range of
iron status (
ferritin < or = 500 ng/ml,
transferrin saturation < or = 25%) were randomly assigned to receive either 1 g of
iron sucrose intravenously in three divided doses (300 mg over 1.5 h on days 1 and 15, 400 mg over 2.5 h on day 29) or no supplemental
iron. No serious
adverse drug events occurred after intravenous
iron administration. The primary end point, peak
hemoglobin increase, was higher (1.3 +/- 1.1 versus 0.7 +/- 1.1, mean +/- SD; P = 0.0028), and
anemia intervention (transfusion, increase in ESA dose, or intravenous
iron therapy not called for in protocol) occurred later (P = 0.0137) and less often in intravenous
iron-treated patients compared with untreated control subjects (one of 66 [1.3%] versus five of 30 [16.7%]). Among patients who did not require intervention,
iron-treated patients showed a calculated net ESA dose decrease compared with untreated control subjects. Baseline
iron status did not predict responsiveness to intravenous
iron therapy. Intravenous
iron sucrose is an effective adjunct to ESA
therapy in anemic patients with PD-dependent
chronic kidney disease and is administered safely as 300 mg over 1.5 h or 400 mg over 2.5 h. Evidence of
iron deficiency at baseline is not required to demonstrate intravenous
iron efficacy.