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MEAN SERUM PHOSPHORUS OF 4.88 mg/dL AT WEEK 56

AURYXIA® (ferric citrate) brought patients within serum phosphorus goal (3.5–5.5 mg/dL),1 with reductions comparable to sevelamer carbonate and/or calcium acetate, and maintained significant reductions compared with placebo.
 
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 DESIGNAURYXIA was studied in a multicenter, randomized, open-label, Phase III trial evaluating the safety and efficacy of AURYXIA as a phosphate binder in controlling serum phosphorus levels in patients with CKD on hemodialysis and peritoneal dialysis over 56 weeks.

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 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.