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PHARMACODYNAMICS IN HYPERPHOSPHATEMIA
IN CHRONIC KIDNEY DISEASE ON DIALYSIS

AURYXIA has been shown to increase serum iron parameters including transferrin saturation (TSAT), ferritin, and iron1

During the 52-week Active Control Period in the Phase III trial in which concomitant use of IV iron was permitted1:

  • Examination of serum iron parameters showed that there is systemic absorption of iron from AURYXIA1
  • Gradual increases in iron parameters occurred over the first 3-6 months and then plateaued2
  • Iron parameters were assessed at study baseline and monitored while on therapy. When required, a reduction in dose or discontinuation of intravenous (IV) iron therapy occurred1

 

  • Over 52 weeks, mean TSAT levels increased from 31% to 39%3

  • Over 52 weeks, mean serum ferritin levels increased from 593 ng/mL to 895 ng/mL3

EACH 1 g FERRIC CITRATE TABLET CONTAINS 210 mg OF FERRIC IRON1

 

TRIAL DESIGN1,4

A multicenter, randomized, open-label, Phase III trial evaluated the safety and efficacy of AURYXIA as a phosphate binder in controlling serum phosphorus levels in adult patients with CKD on hemodialysis and peritoneal dialysis over 56 weeks. Patients had to have serum phosphorus ≥2.5 mg/dL and ≤8.0 mg/dL, serum ferritin <1000 ng/mL, and TSAT <50% at screening. Patients who were intolerant to calcium acetate and sevelamer carbonate were not included in the trial.

The safety and efficacy of AURYXIA was studied in the 52-week Active Control Period (AURYXIA n=292, Active Control n=149). At the final Active Control Period visit, AURYXIA patients were re-randomized to either continue AURYXIA treatment or receive placebo as part of the Placebo-Controlled Period (AURYXIA n=96, Placebo n=96). The primary endpoint of the pivotal trial was the change in serum phosphorus from baseline (Week 52) to Week 56 between AURYXIA and placebo in the 4-week Placebo-Controlled Period.