Clin J Am Soc Nephrol. 2021 Sep 1:CJN.03850321. doi: 10.2215/CJN.03850321. Online ahead of print.
ABSTRACT
Background and objectives Whether iron supplementation in hemodialysis patients could be delivered by less-frequent but higher single doses compared to the currently more common higher-frequency schedules of lower single iron doses is unknown. Design, setting, participants, and measurements We carried out an open label randomized, controlled non-inferiority trial over 40 weeks in prevalent hemodialysis patients (n=142). We administered in total two grams of iron as 100 mg iron sucrose biweekly in a continuous (20 x 100 mg) or 500 mg ferric carboxymaltose every 10 weeks in a periodic (4 x 500 mg) fashion. Primary endpoint was the change in hemoglobin at week 40 from baseline with a non-inferiority margin of -0.8 g/dl. Secondary endpoints were changes in ferritin, transferrin, transferrin saturation and erythropoiesis stimulating agent use. Results 108 patients completed the study. At 40 weeks hemoglobin changed by -0.27 g/dl (95% CI: -0.64 to 0.09) in the iron sucrose arm and by -0.74 g/dl (95% CI: -1.1 to -0.39) in the ferric carboxymaltose arm compared to baseline. Non-inferiority was not established in the per-protocol population as hemoglobin changes compared to baseline differed by -0.47 g/dl (95% CI: -0.95 to 0.01) in the ferric carboxymaltose compared to the iron sucrose arm. Proportional changes from baseline to week 40 differed by -31% (98.3% CI: -52 to -0.1) for ferritin, by 1% (98.3% CI: -7 to 10) for transferrin and by -27% (98.3% CI: -39 to -13) for transferrin saturation in the ferric carboxymaltose compared to the iron sucrose arm. Erythropoiesis stimulating agent dosing did not differ between groups. The overall number of adverse events was similar; however, more infections were observed in the iron sucrose arm. Conclusions An equal cumulative dose of ferric carboxymaltose administered less frequently did not meet non-inferiority for maintaining hemoglobin levels compared to iron sucrose administered more frequently.
PMID:34470831 | DOI:10.2215/CJN.03850321
