A randomized comparison of ferumoxytol and iron sucrose for treating iron deficiency anemia in patients with CKD

Abstract

Background and objectives: Few randomized controlled trials have compared intravenous iron products head to head in CKD patients with iron deficiency anemia. This study compared the efficacy and safety of two intravenous iron products (ferumoxytol [Feraheme injection] and iron sucrose [Venofer]) in patients with CKD and iron deficiency anemia.

Design, setting, participants, & measurements: In this phase II, randomized, open-label, active-controlled, multicenter clinical trial, patients were randomized 1:1 to either 1.02 g ferumoxytol (2 × 510-mg injections) or 1.0 g iron sucrose administered as either a slow injection or infusion (10 doses for dialysis patients and 5 doses for nondialysis patients). Inclusion criteria included hemoglobin<11.0 g/dl, transferrin saturation<30%, and eGFR<60 ml/min per 1.73 m(2) or a diagnosis of underlying CKD (e.g., nephropathy or nephritis). The primary end point was change in hemoglobin from baseline to week 5.

Results: In total, 162 patients were randomized. Demographics were balanced between the treatment groups. Adverse event profiles of the two regimens were fairly similar: overall adverse events, 48% ferumoxytol versus 65% iron sucrose; related adverse events, 10% ferumoxytol versus 16% iron sucrose; and adverse events leading to study discontinuation, 1% ferumoxytol versus 5% iron sucrose. Rates of serious adverse events and related serious adverse events were similar between the ferumoxytol and iron sucrose groups: serious adverse events, 9% versus 7%, respectively and related serious adverse events, 1% versus 1%, respectively. Overall, increases in hemoglobin were similar between treatment groups. Based on an ANOVA model adjusted for baseline hemoglobin level and dialysis status, the least squares mean change from baseline to week 5 was 0.8 ± 0.1 g/dl in the ferumoxytol-treated group and 0.7 ± 0.1 g/dl in the iron sucrose group. The difference in the mean change from baseline between the two treatment groups was 0.1 g/dl (95% confidence interval, -0.2 to 0.4).

Conclusion: In this randomized, controlled trial, ferumoxytol and iron sucrose showed comparable efficacy and adverse events rates.

Trial registration: ClinicalTrials.gov NCT01052779.

Figures

Figure 1.

Comparable hemoglobin change over time by treatment group (intent-to-treat [ITT] population). For missing hemoglobin values, the last observed value was carried forward for imputation. P values were calculated using ANOVA adjusted for baseline hemoglobin level and hemodialysis status. Bars represent 95% confidence intervals. Ferumoxytol, n=80; iron sucrose, n=82.

Figure 2.

Transferrin saturation (TSAT) over time by treatment group (ITT population). Error bars represent 95% confidence intervals. Ferumoxytol, n=80; iron sucrose, n=82.

Figure 3.

Serum ferritin over time by treatment group (ITT population). Error bars represent interquartile ranges. Ferumoxytol, n=80; iron sucrose, n=82.