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
Note: Duration of study periods is not represented to scale.
- 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
The Phase III trial measured safety and efficacy endpoints over 56 weeks
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
- Intolerance to calcium acetate and sevelamer carbonate1
- 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
- Umanath K, Sika M, Niecestro R, et al. Rationale and study design of a three-period, 58-week trial of ferric citrate as a phosphate binder in patients with ESRD on dialysis. Hemodial Int. 2013;17(1):67-74.
- Data on File 4, Keryx Biopharmaceuticals, Inc.