Randomized, multicenter, open-label with blinded end point evaluation which compared the effect of proactive vs reactive IV iron administration on the number of cardiovascular events, deaths, transfusions and dose of erythropoiesis-stimulating agents in patients with ESKD on maintenance hemodialysis. A total of 2,141 participants were randomized 1:1 to receive either a reactive strategy of low dose of intravenous iron sucrose versus a proactive strategy of high dose of intravenous iron sucrose.
During the first year of the trial, the group receiving proactive IV iron had a rapid improvement of their anemia with hemoglobin values averaging 11.2 g/dL versus 10.6 g/dL. The proactive iron strategy patients received less cumulative ESAs at all post baseline time points, thus leading to a potential benefit via decrease in total treatment costs. Ultimately, the proactive IV iron therapy also reduced the incidence of the primary end point – a composite of first non-fatal myocardial infarction, nonfatal stroke, heart failure hospitalization or death.
