Intravenous (IV) administration of ferric carboxymaltose can treat iron deficiency in non-dialysis-dependent CKD (ND-CKD) patients more effectively than oral iron preparations and it is better tolerated, new findings suggest.
In a study of 255 ND-CKD patients with iron-deficiency anemia, researchers demonstrated that IV ferric carboxymaltose increases hemoglobin (Hb) levels and replenishes iron stores better than oral iron, according to an online report in Nephrology Dialysis Transplantation.
“Importantly, because it can be given in large single doses, ferric carboxymaltose is more convenient than oral iron or other intravenous iron preparations for outpatient administration in ND-CKD patients,” said lead investigator Wajeh Y. Qunibi, MD, of the University of Texas Health Science Center in San Antonio.
The study included patients with a glomerular filtration rate of 45 mL/min/1.73 m2 or less, Hb levels of 11 g/dL or less, transferrin saturation (TSAT) of 25% or less, ferritin levels of 300 ng/mL or less, and stable doses of erythropoiesis-stimulating agents. Researchers randomly assigned patients to receive IV ferric carboxymaltose 1000 mg over 15 minutes (with up to two additional doses of 500 mg at two-week intervals) or oral ferrous sulfate 325 mg three times daily for a total of 195 mg of elemental iron daily for 56 days.
The proportion of subjects achieving an Hb increase of 1 g/dL or greater at any time during the study (the primary endpoint) was 60.4% in the ferric carboxymaltose group and 34.7% in the oral iron recipients. Hb levels increased from baseline in both study arms, but were higher at every study time point in the ferric carboxymaltose group.
From baseline to day 56, mean Hb levels rose from 10.15 to 11.19 g/dL in the ferric carboxymaltose recipients and from 10.03 to 10.75 g/dL in the oral iron group, a significant difference between the study arms.
The mean increase in serum ferritin values from baseline was also significantly greater throughout the treatment period in the ferric carboxymaltose group than the oral iron group. At day 56, the mean difference from baseline was 358.8 ng/mL in the ferric carboxymaltose arm compared with 49.4 ng/mL in the oral iron recipients. Moreover, the mean increase in TSAT increased significantly more from baseline to day 56 in the ferric carboxymaltose recipients than the oral iron group (12.1% vs. 7.0%).
The most common adverse events in the ferric carboxymaltose group included peripheral edema, hyperkalemia, urinary tract infection, and hypotension, which occurred in 6.1%, 4.1%, 3.4%, and 3.4% of patients, respectively. The corresponding rates in the oral iron group were 1.9%, 1.0%, 1.0%, and 0%.
Furthermore, the proportion of subjects who experienced at least one possibly drug-related adverse event was significantly lower in the ferric carboxymaltose group than the oral iron group (2.7% vs. 26.2%).