Maintenance intravenous iron in hemodialysis patients to minimize erythropoietin doses: A double-blind, randomized controlled trial (The MAINTAIN IRON Trial)

Abstract

Background: There is no standard regimen for maintenance iron supplementation in chronic hemodialysis patients. We investigated fixed-appropriate doses of intravenous (IV) iron protocols for maintaining hemoglobin levels and minimizing erythropoiesis-stimulating agents (ESA).
Methods: A double-blind, randomized controlled trial was conducted in hemodialysis patients with ferritin levels of 200-700 ng/dl and transferrin saturation (TSAT) 20-40%. Patients were randomized to receive either 100-mg or 200-mg monthly IV iron. ESA was adjusted monthly to maintain Hb of 10-12 g/dl. The primary endpoint was ESA dose at 12 months. Key secondary endpoints were all-cause mortality, cardiovascular events, absolute iron deficiency anemia (IDA), blood transfusion, adverse events, and iron withholding rate.
Results: Of 79 eligible patients, 40 were in the 100-mg IV iron group and 39 in the 200-mg. Mean monthly ESA dose at month 12 was 35,706 ± 21,637 IU in the 100-mg IV iron group versus 26,382±14,983 IU in the 200-mg group (P = 0.03). Twelve patients (30%) in 100-mg group and four patients (10.5%) in 200-mg one had IDA (P = 0.05). Three patients in each group died (P = 0.9). There were no significant differences in hospitalization, venous access thrombosis, and infection rates in both groups, but slightly higher in the 200-mg cohort. The withholding rate was 25% and 64.1% (P = 0.03).
Conclusion: Monthly 200-mg IV iron doses effectively minimize ESA doses in hemodialysis patients but with a higher withholding rate. 
(Thai Clinical Trials Registry number, TCTR20190707001.)