DEcIDE Comparative Effectiveness of IV Iron Formulations in End Stage Renal Disease

Anemia is a highly prevalent condition among the approximately 500,000 people in the US with end stage renal disease (ESRD) and is associated with increased morbidity, mortality, and healthcare costs. The anemia of ESRD is managed primarily through treatment with recombinant human erythropoietin and the administration of intravenous iron. Currently, two formulations of iron are in widespread use in dialysis patients: iron sucrose and sodium ferric gluconate. Although these compounds are distinct molecular entities and possess different pharmacokinetic properties, there are no data from large populations on the head-to-head safety or effectiveness of these formulations. There is also little evidence regarding the optimal dosing of intravenous iron. For example, iron can be administered via periodic maintenance doses or given through bolus administrations: a sequence of administrations in which a large amount of iron is given over consecutive dialysis sessions. Sub-optimal use of iron could worsen anemia, lead to hypersensitivity reactions, or lead to excess labile iron in the plasma that may increase risk of cardiovascular events or serious infections. For reasons of cost, it is unlikely that any of these questions will be definitely addressed in a large head-to-head comparative randomized trial. Therefore, we propose to address these important evidence gaps through a large-scale observational study of two large cohorts of dialysis patients.


Principal Investigator: Til Sturmer Task Order PI; Alan Brookhart Task PI

Funding Source: AHRQ

Total Project Period: 7/15/10- 7/14/13