Strong and sustained phosphorus reductions for more than a year of treatment1,2
Give your patients the confidence of sustained phosphorus control
AURYXIA had similar reductions in serum phosphorus compared to Active Control1,2*
Secondary endpoint: treatment difference of 0.02 mg/dL at Week 52 (P=0.89)
AURYXIA (n=292)
Active Control (n=149)

AURYXIA Arm Re-randomization
AURYXIA maintained significant reductions compared to placebo1,2
Primary endpoint: treatment difference of -2.18 mg/dL at Week 56 (P<0.0001)
AURYXIA (n=96)
Placebo (n=96)

AURYXIA Arm Re-randomization
*Active Control=sevelamer carbonate and/or calcium acetate.
AURYXIA maintained mean serum phosphorus levels between 3.5-5.5 mg/dL after a year of treatment (up to 56 weeks)2
Patients on AURYXIA had a mean serum phosphorus level of 7.41 mg/dL at baseline and 4.88 mg/dL at Week 562
VIEW DATA TABLES
Ferric citrate had similar reductions in serum phosphorus compared to Active Control2*
FERRIC CITRATE | ACTIVE CONTROL | ||
---|---|---|---|
Mean Serum Phosphorus (mg/dL) | Mean Serum Phosphorus (mg/dL) | Change From Baseline: Treatment Difference P-Value | |
Baseline (n) | 7.41 (281) | 7.56 (146) | |
Week 12 (n) | 5.38 (281) | 5.34 (146) | 0.65 |
Week 24 (n) | 5.29 (281) | 5.51 (146) | 0.24 |
Week 36 (n) | 5.23 (281) | 5.31 (146) | 0.76 |
Week 48 (n) | 5.34 (281) | 5.51 (146) | 0.39 |
Week 52 (n) | 5.37 (281) | 5.38 (146) | 0.89 |
*Active Control=sevelamer carbonate and/or calcium acetate.
Ferric citrate maintained significant reductions compared to placebo1,2
FERRIC CITRATE | PLACEBO | ||
---|---|---|---|
Mean Serum Phosphorus (mg/dL) | Mean Serum Phosphorus (mg/dL) | Change From Baseline: Treatment Difference P-Value | |
Week 52 (n) | 5.12 (91) | 5.44 (91) | |
Week 53 (n) | 4.89 (81) | 6.57 (87) | <0.0001 |
Week 54 (n) | 4.76 (90) | 6.88 (90) | <0.0001 |
Week 55 (n) | 4.73 (91) | 6.88 (91) | <0.0001 |
Week 56 (n) | 4.88 (91) | 7.23 (91) | <0.0001 |
SEE TRIAL DESIGN
Trial design1,3
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. Eligible patients were on dialysis for ≥3 months before screening, were prescribed 3 to 18 pills/day of commercially available phosphate binder, and had serum ferritin <1000 ng/mL serum TSAT <50%, and serum phosphorus ≥2.5 and ≤8.0 mg/dL at the screening visit. 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.
CKD=chronic kidney disease; TSAT=transferrin saturation; Active Control=sevelamer carbonate and/or calcium acetate.