Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease

Summary

To evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA in subjects with CKD

Timeline

Start

2016-12-01

Primary completion

2018-01-18

Completion

2018-10-10

Outcome

Met primary endpoint

registry analysis (superiority test); Oral Ferric Maltol vs Oral Placebo; p = 0.0149; Mean Difference (Final Values) 0.52 (95% CI 0.102 to 0.930) NCT02968368 ↗

paper 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). PMID 34029682 ↗

release “The paper concluded that the AEGIS-CKD trial shows that oral ferric maltol raises and sustains haemoglobin” shieldtherapeutics.com ↗

release “Ferric maltol demonstrates statistically significant (16 weeks) and sustained (up to 52 weeks) increase in haemoglobin, compared to placebo, in subjects with chronic kidney” shieldtherapeutics.com ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ferric maltol	Small molecule	30 mg	Oral

Indications