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PIVOTAL PHASE III TRIAL

AURYXIA® (ferric citrate) was studied in a multicenter, randomized, open-label, Phase III trial that evaluated 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)

 

 

Study Design

The safety and efficacy of AURYXIA was studied in a multicenter, randomized, open-label, Phase III trial of 441 hyperphosphatemia patients with chronic kidney disease on hemodialysis and peritoneal dialysis over 56 weeks.

The primary endpoint of the pivotal trial was 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.

 

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.

FormulationEach AURYXIA® (ferric citrate) tablet contains 210 mg of ferric iron, equivalent to 1 g of ferric citrate.