Less frequent, higher iron dose fails to meet noninferiority for hemodialysis treatment
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Less frequent, higher doses of iron supplementation for patients on hemodialysis did not meet noninferiority standards for maintaining hemoglobin levels compared with the traditional treatment of more frequent doses, according to a study.
In a prospective, randomized, open-label, 40 week trial in Austria, investigators assessed 108 adult patients on hemodialysis. Patients showed no sign of infection or malignant disease and had a ferritin of less than 1,000 ng/mL and a baseline hemoglobin of 8.5 g/dL.
“It was the primary study goal to demonstrate noninferiority of the periodic dosing arm (ferric carboxymaltose) compared with the continuous dosing arm (iron sucrose) with respect to the mean change of hemoglobin at the end of the study,” Bernhard Bielesz MD, and colleagues wrote in the study published in the Clinical Journal of the American Society of Nephrology. “A maximum difference between respective hemoglobin changes from baseline to 40 weeks of 20.8 g/dL was considered clinically negligible and prespecified as the noninferiority margin.”
During the course of the trial, equal cumulative 2-g doses of IV iron were administered to both groups. Researchers administered ferric carboxymaltose as a fixed dose of 500 mg to one group at every study appointment (defined by researchers as starting at day 1 of the trial, and every 10 weeks after across the trial period) for 30 weeks and iron sucrose as a fixed dose of 100 mg biweekly for 38 weeks.
“We found that providing more iron less often (ferric carboxymaltose given every 10 weeks) was less effective compared to giving less iron more often (iron sucrose biweekly) in maintaining hemoglobin levels and iron stores in hemodialysis patients,” Bielesz told Healio Nephrology. “This, in spite of the fact that overall cumulative doses were equal.”
At 40 weeks, hemoglobin in the iron sucrose arm of the study changed by - 0.27 g/dL and by-0.74 g/dL in the ferric carboxymaltose arm. “Noninferiority was not established in the pre-protocol as hemoglobin changes compared with baseline differed by –0.47 g/dL ... in the ferric carboxymaltose arm compared with the iron sucrose arm," the author's wrote.
“I was expecting to see comparable efficacy, so for me it was unexpected,” Bielesz said. “I think this is a piece of evidence against giving iron to hemodialysis patients at too long intervals, although we observed more infections in the more frequently iron sucrose-treated patients. However, the latter aspect is just a safety signal as our study was not powered for safety.”
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