Periodic high-dose intravenous (IV) iron is safe in patients receiving hemodialysis, but continuous low-dose IV iron appears more effective at maintaining hemoglobin (Hb) and iron stores, investigators discussed at the American Society of Nephrology’s Kidney Week 2020 Reimagined virtual conference.
Bernhard O. Bielesz, MD, of Vienna University in Vienna, Austria, and colleagues compared 2 regimens providing the same cumulative dose of 2 g iron in 142 patients receiving hemodialysis. Ferric carboxymaltose (FCM), which is not yet approved for this use, was administered as a high-dose bolus (500 mg every 10 weeks) and iron sucrose (IS) was administered according to a low-dose maintenance iron protocol (100 mg every 2 weeks).
At week 40, Hb was 0.47 g/dL lower in the FCM than the IS group and failed to meet the noninferiority criterion of -0.8 g/dL. In the intention-to-treat analysis, Hb was a significant 0.46 g/dL lower in the FCM arm. With respect to iron parameters at week 40, ferritin was 29.7% lower (change from baseline -33.6% vs 3.4%) and transferrin saturation (TSAT) was 27.7% lower (change from baseline -19.4% vs 6%) in the FCM vs IS arm, respectively. Cumulative doses of erythropoiesis-stimulating agents (ESAs) did not differ between groups. Importantly, infections occurred more often in the IS arm.
“Periodic FCM can be safely administered at doses of 500 mg in hemodialysis patients,” Dr Bielesz’ team concluded. “IS administered more frequently at lower doses maintained hemoglobin and iron stores more effectively than FCM administered less frequently but at higher doses.”
Disclosure: This clinical trial was supported by Vifor. Please see the original reference for a full list of authors’ disclosures.
Bielesz BO, Lorenz M, Monteforte R, et al. Continuous low-dose iron sucrose or periodic high-dose ferric carboxymaltose therapy in hemodialysis patients (COPEFER): a randomized controlled noninferiority trial. Presented at: Kidney Week 2020 Reimagined, October 19-25, 2020. Poster PO2624.