Key Points
- Ferric carboxymaltose given as an IV bolus push injection is well tolerated and effective in correcting hemoglobin levels in hemodialysis patients with iron-deficiency anemia.
- Nearly 62% of patients were treatment responders, which the investigators defined as patients who had a 1.0 g/dL or greater increase in hemoglobin from baseline.
- The increase in hemoglobin can be attributed solely to efficient iron utilization.
SAN DIEGO—Ferric carboxymaltose (FCM) given as an IV bolus push injection is well tolerated and effective in correcting hemoglobin levels in hemodialysis (HD) patients with iron-deficiency anemia, Romanian researchers reported in a study presented at American Society of Nephrology’s Renal Week.
The findings come from a multicenter, open-label phase 2 study by Adrian C. Covic, MD, of Parhon University Hospital in Lasi and Gabriel Mircescu, MD, PhD, of Carol Davila University of Medicine and Pharmacy in Bucharest. The study enrolled 163 HD patients who received 200 mg of iron as FCM via IV bolus push injection into the dialysis venous line two to three times weekly for up to six weeks.
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Nearly 62% of patients were treatment responders, which the investigators defined as patients who had a 1.0 g/dL or greater increase in hemoglobin from baseline at any time during the study. Their mean baseline hemoglobin levels increased from 9.1 g/dL at baseline to 10.3 g/dL at follow-up.
Mean ferritin levels increased from 67.3 to 333.6 μg/L, and transferrin saturation values rose from 17.4% to 31%.
The mean total cumulative dose of iron as FCM administered was 2,133.3 mg. A total of 193 adverse events (AEs) were reported in 89 (54.6%) of the 163 patients. At least one serious AE occurred in 12 patients (7.4%) patients. Two patients died, one from pulmonary tuberculosis and the other from acute heart failure. None of these AEs were considered to be related to study medication. Only five patients (3.1%) discontinued study medication because of AEs.
As increased doses of erythropoiesis-stimulating agents were not permitted, the authors noted, the increase in hemoglobin can be attributed solely to efficient iron utilization.
