EFFICACY

Proven effective in patients who were previously intolerant of or had an inadequate therapeutic response to traditional oral iron supplements

Without the use of ESAs or IV iron, 52% of patients treated with AURYXIA® (ferric citrate) achieved a hemoglobin (Hgb) increase of ≥1.0 g/dL at any time point by Week 16

Hemoglobin increases were seen as early as 1-2 weeks with AURYXIA1

18±1% increase in mean transferrin saturation (TSAT) at Week 16 from baseline

Patients on AURYXIA also achieved a mean increase in serum ferritin of 163±9 ng/mL from baseline (85.9 ng/mL) at Week 161

Trial Design

A 16-week, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of AURYXIA for the treatment of iron deficiency anemia in adult patients with CKD not on dialysis. Patients were randomized to treatment with either AURYXIA (n=117) or placebo (n=117), had hemoglobin levels ≥9.0 g/dL and ≤11.5 g/dL and who were previously intolerant of or had inadequate therapeutic response to traditional oral iron supplements. The primary endpoint was the proportion of patients achieving a ≥1.0 g/dL increase in hemoglobin at any time point during the 16-week efficacy period. Use of oral iron, IV iron, and ESAs was not permitted at any time during the trial.

Studied in a Phase III pivotal trial of patients who previously failed oral iron therapy

Primary efficacy endpoint

  • Proportion of patients achieving an increase in hemoglobin concentration of ≥1.0 g/dL from baseline at any point through the end of the randomized period (Week 16)

Key secondary efficacy endpoints included1:

  • Mean changes in hemoglobin, TSAT, ferritin, and phosphorus from baseline to Week 16
  • Proportion of patients experiencing a sustained treatment effect on hemoglobin (≥0.75 g/dL mean change in hemoglobin from baseline over any 4-week period provided that an increase of at least 1.0 g/dL had occurred during that 4-week period)

Key inclusion criteria

  • Adult patients with CKD not on dialysis (eGFR <60 mL/min/1.73 m2) and iron deficiency anemia (hemoglobin ≥9.0 and ≤11.5 g/dL, ferritin ≤200 ng/mL and TSAT ≤25%) at screening
  • Intolerant of or have had an inadequate therapeutic response to oral iron supplements

Key exclusion criteria4

  • IV iron, ESAs, or blood transfusion administered within 4 weeks prior to screening
  • Serum phosphorus <3.5 mg/dL at screening
  • Cause of anemia other than iron deficiency or CKD
ESAs=erythropoiesis-stimulating agents; IV=intravenous; eGFR=estimated Glomerular Filtration Rate.
References
  1. Fishbane S, Block GA, Loram L, et al. Effects of ferric citrate in patients with nondialysis-dependent CKD and iron deficiency anemia. J Am Soc Nephrol. 2017;28(6):1851-1858.
  2. Data on File 16, Keryx Biopharmaceuticals, Inc.
  3. Data on File 14, Keryx Biopharmaceuticals, Inc.
  4. Supplement to: Fishbane S, Block GA, Loram L, et al. Effects of ferric citrate in patients with nondialysis-dependent CKD and iron deficiency anemia. J Am Soc Nephrol. 2017;28(6):1851-1858.