CKD: FDA approves expanded indication for ferric citrate

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  • The FDA has approved an expanded indication for ferric citrate tablets (Auryxia), allowing their use for the treatment of iron deficiency anemia in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD).

Why this matters

  • Use of the phosphate binder was previously limited to patients on dialysis.
  • For patients not on dialysis, the starting dose is 1 tablet (rather than 2), three times daily.

Study design

  • Approval was based on phase 3 data from a 16-wk randomized, double-blind, placebo-controlled efficacy trial, followed by an 8-wk open-label safety extension study, in 232 adults (mean age, 65 y; female, 63%)  with stage III-V NDD-CKD.
  • Hb levels ranged from 9.0-11.5 g/dL.
  • Funding: Keryx Biopharmaceuticals, Inc.

Key results

  • Ferric citrate was significantly more effective than placebo for achieving an increase in Hb ≥1.0 g/dL at any point over the 16-wk period (52.1% vs 19.1%; P<.001).
  • Proportion of patients achieving a sustained increase in Hb (≥0.75 g/dL during any 4-wk period) was likewise higher (49% vs 15%; P<.001).
  • Mean change in Hb from baseline was 0.75±0.09 g/dL.
  • Most common adverse events were diarrhea (21%), constipation (19%), discolored feces (15%), nausea (11%), abdominal pain (6%), and hyperkalemia (7%).

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