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MEAN SERUM PHOSPHORUS OF 4.88 mg/dL AT WEEK 561

AURYXIA brought patients within serum phosphorus goal (3.5–5.5 mg/dL),2 with reductions comparable to sevelamer carbonate and/or calcium acetate, and maintained significant reductions compared with placebo3

 

 

In the 52-week Active Control Period (selected secondary endpoint)1

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

 

In the 4-week Placebo-Controlled Period (primary endpoint)3

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

 

 

TRIAL DESIGN3,4A 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.