Publication/Presentation Date

12-1-2021

Abstract

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.

Volume

78

Issue

6

First Page

846

Last Page

856

ISSN

1523-6838

Disciplines

Medicine and Health Sciences

PubMedID

34029682

Department(s)

Department of Medicine

Document Type

Article

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