MEAN SERUM PHOSPHORUS OF 4.88 mg/dL AT WEEK 561
AURYXIA brought patients within serum phosphorus goal (3.5–5.5 mg/dL),2 with reductions comparable to sevelamer carbonate and/or calcium acetate, and maintained significant reductions compared with placebo3
In the 52-week Active Control Period (selected secondary endpoint)1
- Treatment difference: 0.02 mg/dL at Week 52 (P=0.89)
In the 4-week Placebo-Controlled Period (primary endpoint)3
- Treatment difference: -2.18 mg/dL at Week 56 (P<0.0001)
TRIAL DESIGN3,4A 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® (ferric citrate) is indicated for:
- The control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis
IMPORTANT SAFETY INFORMATION
AURYXIA® (ferric citrate) is contraindicated in patients with iron overload syndromes, e.g., hemochromatosis
WARNINGS AND PRECAUTIONS
- Iron Overload: Increases in serum ferritin and transferrin saturation (TSAT) were observed in clinical trials with AURYXIA in patients with chronic kidney disease (CKD) on dialysis treated for hyperphosphatemia, which may lead to excessive elevations in iron stores. Assess iron parameters prior to initiating AURYXIA and monitor while on therapy. Patients receiving concomitant intravenous (IV) iron may require a reduction in dose or discontinuation of IV iron therapy
- Risk of Overdosage in Children Due to Accidental Ingestion: Accidental ingestion and resulting overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Advise patients of the risks to children and to keep AURYXIA out of the reach of children
The most common adverse reactions reported with AURYXIA in clinical trials were:
- Hyperphosphatemia in CKD on Dialysis: Diarrhea (21%), discolored feces (19%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%)
- Pregnancy and Lactation: There are no available data on AURYXIA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. However, an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. Data from rat studies have shown the transfer of iron into milk, hence, there is a possibility of infant exposure when AURYXIA is administered to a nursing woman
To report suspected adverse reactions, contact Akebia Therapeutics, Inc. at 1-844-445-3799
- Data on File 1, Akebia Therapeutics, Inc.
- National Kidney Foundation. K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis. 2003;42(4 Suppl 3):S1-S201.
- AURYXIA [package insert]. Cambridge, MA: Akebia Therapeutics, Inc.; 2017.
- 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.