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Abstract: TH-PO245

Effect of Oral Ferric Maltol on Iron Parameters in Patients with CKD and Varying Degrees of Inflammation; A Randomized, Controlled Trial

Session Information

Category: Anemia and Iron Metabolism

  • 202 Anemia and Iron Metabolism: Clinical

Author

  • Kopyt, Nelson P., Lehigh Valley Hospital, Allentown, Pennsylvania, United States

Group or Team Name

  • AEGIS-CKD Study Group
Background

The incidence of anemia increases with the severity or stage of CKD. Further, some patients with CKD have chronic inflammation, which can reduce the absorption and utilization of iron, including that from oral ferrous iron products. Alternative intravenous iron administration can be inconvenient and has the risk of allergic reactions or iron overload. Patients with CKD and iron-deficiency anemia (IDA) would benefit from an oral iron replacement therapy that is effective irrespective of the degree of underlying inflammation.

Methods

In this phase 3, multicenter, randomized, controlled trial (NCT02968368), patients aged ≥18 years with CKD (estimated glomerular filtration rate ≥15 to <60 mL/min/1.73 m2) and IDA were randomized 2:1 to ferric maltol or placebo orally 30 mg twice daily for 16 weeks. IDA was defined as hemoglobin ≥8.0 g/dL to <11.0 g/dL, and either ferritin <250 μg/L with transferrin saturation (TSAT) <25% or ferritin <500 μg/L with TSAT <15%. Changes in iron storage indices were assessed at weeks 4, 8, and 16 for different levels of high-sensitivity C-reactive protein (hsCRP).

Results

111 patients were randomized to ferric maltol and 56 to placebo. In the intent-to-treat population (last observation carried forward), the mean change in ferritin from baseline to week 16 for ferric maltol vs placebo was 25.32 vs –3.67 µg/L for those with hsCRP <1 mg/L, 32.54 vs –3.88 µg/L for those with hsCRP ≥1 to ≤3 mg/L, and 23.78 vs –12.87 µg/L for those with hsCRP >3 mg/dL. Corresponding changes in TSAT concentrations from baseline to week 16 were 3.95% vs –1.89% in ferric maltol recipients vs placebo recipients with hsCRP <1 mg/L, 3.31% vs –0.12% in those with hsCRP ≥1 to ≤3 mg/L, and 3.86% vs –0.97% in those with hsCRP >3 mg/dL.

Conclusion

Ferric maltol improved iron parameters – ferritin and TSAT – from baseline to week 16 vs placebo in patients with IDA and CKD irrespective of the degree of chronic inflammation.

Funding

  • Commercial Support