Mechanism of action of AURYXIA
Watch this video and learn how the unique formulation of AURYXIA works in the body to help manage adult patients’ phosphorus levels.1,2
Chronic kidney disease, CKD, is characterized by a gradual loss of kidney function.3 The kidneys play an important role in regulating the amount of phosphorus in blood, removing excess phosphorus for renal excretion.3,4 Loss of kidney function in end stage renal disease diminishes the kidney’s ability to control serum phosphate levels, causing hyperphosphatemia.4
AURYXIA is a unique formulation of ferric citrate coordination complexes for control of serum phosphorus levels in adults with CKD receiving dialysis.1,2,5 AURYXIA is an iron-based, calcium-free, non-chewable phosphate binder, which after swallowing reaches the gastrointestinal tract where ferric iron binds to dietary phosphates to produce ferric phosphate, an insoluble compound that is readily excreted in fecal matter.1,2,6-8 By lowering gastrointestinal phosphate absorption, AURYXIA reduces serum phosphorus concentrations in patients with CKD receiving dialysis.1,2,6-8
How AURYXIA lowers phosphate levels
AURYXIA is a unique formulation of ferric citrate coordination complexes for control of serum phosphorus levels in adults with CKD receiving dialysis.1,2,5*
Ferric iron binds to dietary phosphate in the GI tract to produce ferric phosphate1
This compound is insoluble and is readily excreted in the stool1
By lowering gastrointestinal phosphate absorption, AURYXIA reduces serum phosphorus concentrations1
*CKD=chronic kidney disease.
See how AURYXIA helped patients reach their target goals
AURYXIA helped patients reach and stay in the range of 3.5-5.5 mg/dL during a 56-week trial9,10
Patients had a mean serum phosphorus level of 7.41 mg/dL at baseline and 4.88 mg/dL at Week 56.9
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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.