ThIs site is for U.S. healthcare professionals only
Menu

EFFICACY RESULTS

Proven efficacy in controlling serum phosphorus

 

AURYXIA® (ferric citrate) brought patients to goal (3.5–5.5 mg/dL),1 with serum phosphorus reductions comparable to sevelamer carbonate and/or calcium acetate, and maintained significant reductions compared with placebo.

  • Proven control of serum phosphorus within KDOQI guidelines (4.88 mg/dL at Week 56)1,2

 

efficacy

 

In the 52-week Active Control Period (selected secondary endpoint)

  • Treatment difference: 0.02 mg/dL at Week 52 (P=0.89)2

 

In the 4-week Placebo-Controlled Period (primary endpoint)

  • Treatment difference: -2.18 mg/dL at Week 56 (P<0.0001)

 

 

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.