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STUDIED IN A LONG-TERM, PHASE III PIVOTAL TRIAL

A multicenter, randomized, open-label, Phase III trial of AURYXIA® (ferric citrate) that studied the safety and efficacy of AURYXIA in hyperphosphatemia patients with chronic kidney disease (CKD) on hemodialysis and peritoneal dialysis over 56 weeks.1

 

trialdesign

Note: Duration of study periods is not represented to scale.

 

Randomization

  • Out of the 292 patients randomized to AURYXIA during the 52-week Active Control Period, 193 completed the study2
    • Of these patients, 192 were randomized 1:1 to either AURYXIA or placebo during the 4-week Placebo-Controlled Period
  • For Active Control, 149 entered the Active Control Period, with 111 completing the entire 52-week study period2

 

Trial Endpoints

The Phase III trial measured safety and efficacy endpoints over 56 weeks

PRIMARY ENDPOINT1:
Placebo-Controlled Period (Week 52–Week 56)

  • Change in serum phosphorus from baseline (Week 52) to Week 56 between AURYXIA and placebo

 

SECONDARY ENDPOINTS INCLUDED1:
Active Control Period (Week 0–Week 52)

 

MAIN CRITERIA FOR INCLUSION1
  • Age ≥18 years
  • On thrice-weekly hemodialysis, or peritoneal dialysis, for at least the previous 3 months
  • Taking 3 to 18 pills/day of calcium acetate, calcium carbonate, lanthanum carbonate, and/or sevelamer (carbonate or hydrochloride or equivalent sevelamer powder), any combination of these agents, or any other agent serving as a phosphate binder
  • In addition, subjects had to have serum phosphorus ≥2.5 mg/dL and ≤8.0 mg/dL, serum ferritin <1000 ng/mL, and TSAT <50% at screening

 

EXCLUSION CRITERIA
  • Intolerance to calcium acetate and sevelamer carbonate1

 

ALLOWED THERAPIES1
  • IV iron therapy was permitted for subjects with serum ferritin ≤1000 ng/mL and TSAT ≤30%. The dose and specific intravenous (IV) iron preparation administered was at the discretion of the Investigator. The use of vitamin D and its analogues, cinacalcet, dialysate calcium concentration, and choice and dose of erythropoiesis-stimulating agent was at the discretion of the Investigator