RATIONALE & OBJECTIVE: Iron-deficiency anemia is common in patients with chronic kidney disease (CKD) not requiring kidney replacement therapy (KRT). We evaluated effects of oral iron replacement therapy with ferric maltol in these patients.
STUDY DESIGN: Phase 3, double-blind, randomized, placebo-controlled trial (AEGIS-CKD) and open-label extension.
SETTING & PARTICIPANTS: Adults with stage 3 or 4 CKD and iron-deficiency anemia at 30 US centers.
INTERVENTION: Oral ferric maltol at 30mg or placebo twice daily for 16 weeks (2:1 randomization) followed by ferric maltol at 30mg twice daily for up to 36 weeks (all patients).
OUTCOME: Change from baseline in hemoglobin (primary end point at week 16), ferritin, transferrin saturation, and serum iron; safety.
RESULTS: 167 patients were randomized (ferric maltol, n=111; placebo, n=56). At week 16, hemoglobin had increased significantly with ferric maltol versus placebo (least-squares mean difference: 0.5±0.2 [SE] g/dL; 95% CI, 0.1-0.9; P=0.01). Ferritin, transferrin saturation, and serum iron increased with ferric maltol but declined with placebo (all P
LIMITATIONS: Heterogeneity in baseline ferritin levels; high proportion of female participants; single-arm open-label extension.
CONCLUSIONS: Ferric maltol was associated with statistically significant (week 16) and sustained (up to week 52) increases in hemoglobin and iron indices in patients with CKD and iron deficiency, and was well tolerated during treatment for up to 52 weeks.
FUNDING: Funded by Shield Therapeutics (UK) Ltd.
TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study number NCT02968368.
Published In/Presented At
Pergola, P. E., & Kopyt, N. P. (2021). Oral Ferric Maltol for the Treatment of Iron-Deficiency Anemia in Patients With CKD: A Randomized Trial and Open-Label Extension. American journal of kidney diseases : the official journal of the National Kidney Foundation, 78(6), 846–856.e1. https://doi.org/10.1053/j.ajkd.2021.03.020
Medicine and Health Sciences
Department of Medicine