PHARMACODYNAMICS IN HYPERPHOSPHATEMIA
IN CHRONIC KIDNEY DISEASE ON DIALYSIS
AURYXIA has been shown to increase serum iron parameters including transferrin saturation (TSAT), ferritin, and iron1
During the 52-week Active Control Period in the Phase III trial in which concomitant use of IV iron was permitted1:
- Examination of serum iron parameters showed that there is systemic absorption of iron from AURYXIA1
- Gradual increases in iron parameters occurred over the first 3-6 months and then plateaued2
- Iron parameters were assessed at study baseline and monitored while on therapy. When required, a reduction in dose or discontinuation of intravenous (IV) iron therapy occurred1
- Over 52 weeks, mean TSAT levels increased from 31% to 39%3
- Over 52 weeks, mean serum ferritin levels increased from 593 ng/mL to 895 ng/mL3
EACH 1 g FERRIC CITRATE TABLET CONTAINS 210 mg OF FERRIC IRON1
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. Patients had to have serum phosphorus ≥2.5 mg/dL and ≤8.0 mg/dL, serum ferritin <1000 ng/mL, and TSAT <50% at screening. 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.
- AURYXIA [package insert]. Cambridge, MA: Akebia Therapeutics, Inc.; 2017.
- Umanath K, Jalal DI, Greco BA, et al; for Collaborative Study Group. Ferric citrate reduces intravenous iron and erythropoiesis-stimulating agent use in ESRD. J Am Soc Nephrol. 2015;26(10):2578-2587.
- Data on File 2, Akebia Therapeutics, Inc.
- Umanath K, Sika M, Niecestro R, et al; for Collaborative Study Group. 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.