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PHARMACODYNAMICS

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

Examination of serum iron parameters has shown that AURYXIA is associated with systemic absorption of iron.

Increases in iron parameters were gradual, allowing for monitoring of serum iron parameters and reductions in dose or discontinuation of IV iron therapy as needed.

 

AURYXIA increases TSAT

  • Over 52 weeks, AURYXIA increased TSAT levels by 8 percentage points (31% to 39%)

AURYXIA increases serum ferritin

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

AURYXIA increases serum iron

  • Over 52 weeks, AURYXIA increased serum iron levels by 15 mcg/dL (73 mcg/dL to 88 mcg/dL)
Study Design

The safety and efficacy of AURYXIA was studied in a multicenter, randomized, open-label, Phase III trial of 441 hyperphosphatemia patients with chronic kidney disease on hemodialysis and peritoneal dialysis over 56 weeks.

The primary endpoint of the pivotal trial was change in serum phosphorus from baseline (Week 52) to Week 56 between AURYXIA and placebo in a 4-week efficacy assessment (Placebo-Controlled Period), which followed a 52-week safety assessment (Active Control Period). 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.


FormulationEach AURYXIA® (ferric citrate) tablet contains 210 mg of ferric iron, equivalent to 1 g of ferric citrate.