Maintenance hemodialysis is treatment routinely given to patients with end-stage renal disease. Intravenous iron is a standard treatment for patients undergoing maintenance hemodialysis, but the outcomes are largely unknown. The objective of this study is to evaluate the overall outcomes of intravenous iron treatment in patients undergoing maintenance hemodialysis.

This open-label, multicenter, randomized trial included a total of 2,141 patients undergoing maintenance hemodialysis. The patients were randomly assigned in a 1:1 ratio to receive intravenous high-dose iron sucrose (n=1,093) or intravenous low-dose iron sucrose (n=1,048). The median monthly dose in the high-dose group was 264 mg, as compared with 145 mg in the low-dose group. The non-inferiority of high-dose and low-dose iron was established, and the primary outcome of the study was cardiovascular events, including nonfatal myocardial infarction, nonfatal stroke, or death.

During the median follow-up of 2.1 years, 320 patients (29.3%) patients in the high-dose group gad a primary outcome event, as compared with 338 (32.3%) in the low-dose group. The recurrent-events approach suggested that there were 429 events in the high-dose group and 507 in the low-dose group.

The findings conclude that high-dose intravenous iron regimen administered in patients undergoing hemodialysis was superior to a low-dose regimen.