The AEGIS-CKD Phase 3 trial evaluated the effects of oral iron replacement therapy with ferric maltol in adults with stage 3 or 4 chronic kidney disease (CKD) and iron-deficiency anemia. The randomized, placebo-controlled trial, followed by an open-label extension at 30 US centers, involved administering ferric maltol or placebo for 16 weeks, then switching all patients to ferric maltol for up to 36 additional weeks. The primary outcome was the change in hemoglobin levels at week 16, along with ferritin, transferrin saturation, and serum iron measurements.

Results showed significant hemoglobin increases in the ferric maltol group compared to placebo, with improved iron indices. These benefits were sustained up to week 52, even in patients initially on placebo. This suggests ferric maltol is a viable treatment for this patient group, offering a promising approach for managing iron-deficiency anemia in CKD without kidney replacement therapy.

Reference: Pergola PE, Kopyt NP. Oral Ferric Maltol for the Treatment of Iron-Deficiency Anemia in Patients With CKD: A Randomized Trial and Open-Label Extension. Am J Kidney Dis. 2021 Dec;78(6):846-856.e1. doi: 10.1053/j.ajkd.2021.03.020. Epub 2021 May 23. PMID: 34029682.