Abstract | RATIONALE & OBJECTIVE: STUDY DESIGN: Phase 3, double-blind, randomized, placebo-controlled trial (AEGIS-CKD) and open-label extension. SETTING & PARTICIPANTS: 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: 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<0.05). Hemoglobin levels were sustained up to week 52 in patients continuing ferric maltol and increased in patients switching from placebo to ferric maltol. The most frequent adverse events were gastrointestinal (randomized phase: 41% vs 30% [ ferric maltol vs placebo]; open-label phase: 56% vs 46%, respectively). Adverse events led to treatment withdrawal in 7 patients (6%) receiving ferric maltol and 5 patients (9%) receiving placebo during double-blind treatment, and 11 patients (9%) during the open-label extension. 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: TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study number NCT02968368.
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Authors | Pablo E Pergola, Nelson P Kopyt |
Journal | American journal of kidney diseases : the official journal of the National Kidney Foundation
(Am J Kidney Dis)
Vol. 78
Issue 6
Pg. 846-856.e1
(12 2021)
ISSN: 1523-6838 [Electronic] United States |
PMID | 34029682
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
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Copyright | Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved. |
Chemical References |
- Ferric Compounds
- Pyrones
- ferric maltol
|
Topics |
- Anemia, Iron-Deficiency
(drug therapy, etiology)
- Female
- Ferric Compounds
- Humans
- Iron Deficiencies
- Pyrones
- Renal Insufficiency, Chronic
(complications)
|