PHARMACODYNAMICS IN HYPERPHOSPHATEMIA
IN CHRONIC KIDNEY DISEASE ON DIALYSIS
AURYXIA® (ferric citrate) has been shown to increase serum iron parameters including transferrin saturation (TSAT) and ferritin
In addition to effects on serum phosphorus levels, examination of serum iron parameters has shown that there is systemic absorption of iron from AURYXIA
During the 52-week Active Control Period, gradual increases in iron parameters occurred over the first 3-6 months and then plateaued1
- Over 52 weeks, AURYXIA increased mean TSAT levels by 8 percentage points (31% to 39%)
- Over 52 weeks, AURYXIA increased mean serum ferritin levels from 593 ng/mL to 895 ng/mL
EACH 1 g FERRIC CITRATE TABLET CONTAINS 210 mg OF FERRIC IRON
- 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 occurred
- There were no incidences of iron overload related to AURYXIA in clinical trials
- One case of elevated iron in the liver was reported in a patient administered IV iron and AURYXIA. The event was considered not related to AURYXIA by the investigator
AURYXIA was studied in a multicenter, randomized, open-label, Phase III trial evaluating the safety and efficacy of AURYXIA as a phosphate binder in controlling serum phosphorus levels in patients with CKD on hemodialysis and peritoneal dialysis over 56 weeks.
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 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.
- Umanath K, Jalal DI, Greco BA, et al. 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, Keryx Biopharmaceuticals, Inc.