Intravenous (IV) high-dose iron does not increase the risk of infection in patients on hemodialysis (HD) compared with IV low-dose iron, new study findings suggest.

In a prespecified secondary analysis of data from the PIVOTAL (Proactive IV Iron Therapy in Haemodialysis Patients) trial, investigators found no significant between IV high-dose and low-dose iron therapy in event rates for all infections (46.5% vs 45.5%, respectively), rates of hospitalization for infection (29.6% vs 29.3%), and death from infection (46% vs 41%), according to study findings published in the Journal of the American Society of Nephrology.

“Given the potential cardiovascular benefits seen in the PIVOTAL trial, this analysis provides further support for administering higher doses of intravenous iron than are currently given in many units worldwide,” a team led by Iain C. Macdougall, MBChB, MD, of Kings College Hospital in London, concluded.

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Dr Macdougall and his collaborators found a significant association between the risk of a first cardiovascular event and any infection in the previous 30 days. In addition, patients who dialyzed with a catheter compared with had an arteriovenous fistula for vascular access had a significantly higher incidence of any infection, hospitalization for infection, or fatal infection, IV iron dosing had no effect on these outcomes, the investigators concluded.

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Regarding study limitations, the authors noted that their study was a secondary analysis and not the primary outcome of the study. Although the PIVOTAL trial is the largest randomized trial of iron in any patient population, it was conducted using a cohort of patients receiving HD, Dr Macdougall and his colleagues explained. “This is a very specific group of patients, with different infection risks and profiles from other patient groups,” they wrote. “Given the high incidence of infection in this group of patients, it was a good way to test the hypothesis of iron treatment on the risk of infection, but extrapolating the findings to other patient populations may not be justified.”

The authors also pointed out that the iron sucrose was the IV iron preparation used in the PIVOTAL trial, and it is unknown whether their findings from the secondary analysis can be extrapolated to other IV iron preparations.


Macdougall IC, Bhandari S, White C, et al. Intravenous iron dosing and infection risk in patients on hemodialysis: A prespecified secondary analysis of the PIVOTAL trial [published online April 6, 2020]. J Am Soc Nephrol.  doi: 10.1681/ASN.2019090972