Strong and sustained phosphorus reductions for more than a year of treatment1,2

Give your patients the confidence of sustained phosphorus control

AURYXIA had similar reductions in serum phosphorus compared to Active Control1,2*

Secondary endpoint: treatment difference of 0.02 mg/dL at Week 52 (P=0.89)

AURYXIA (n=292)

Active Control (n=149)

Secondary endpoint

AURYXIA Arm Re-randomization

AURYXIA maintained significant reductions compared to placebo1,2

Primary endpoint: treatment difference of -2.18 mg/dL at Week 56 (P<0.0001)

AURYXIA (n=96)

Placebo (n=96)

Primary endpoint

AURYXIA Arm Re-randomization

*Active Control=sevelamer carbonate and/or calcium acetate.

AURYXIA maintained mean serum phosphorus levels between 3.5-5.5 mg/dL after a year of treatment (up to 56 weeks)2

Patients on AURYXIA had a mean serum phosphorus level of 7.41 mg/dL at baseline and 4.88 mg/dL at Week 562

Ferric citrate had similar reductions in serum phosphorus compared to Active Control2*

FERRIC CITRATEACTIVE CONTROL
 Mean Serum
Phosphorus
(mg/dL)
Mean Serum
Phosphorus
(mg/dL)
Change from Baseline: Treatment Difference P-Value
Baseline
(n)
7.41
(281)
7.56
(146)
Week 12
(n)
5.38
(281)
5.34
(146)
0.65
Week 24
(n)
5.29
(281)
5.51
(146)
0.24
Week 36
(n)
5.23
(281)
5.31
(146)
0.76
Week 48
(n)
5.34
(281)
5.51
(146)
0.39
Week 52
(n)
5.37
(281)
5.38
(146)
0.89

*Active Control=sevelamer carbonate and/or calcium acetate.


Ferric citrate maintained significant reductions compared to placebo1,2

FERRIC CITRATEPLACEBO
 Mean Serum Phosphorus (mg/dL)Mean Serum Phosphorus (mg/dL)Change from Baseline:Treatment Difference P-Value
Week 52
(n)
5.12
(91)
5.44
(91)
Week 53
(n)
4.89
(81)
6.57
(87)
<0.0001
Week 54
(n)
4.76
(90)
6.88
(90)
<0.0001
Week 55
(n)
4.73
(91)
6.88
(91)
<0.0001
Week 56
(n)
4.88
(91)
7.23
(91)
<0.0001

Trial design1,3

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. Eligible patients were on dialysis for ≥3 months before screening, were prescribed 3 to 18 pills/day of commercially available phosphate binder, and had serum ferritin <1000 ng/mL serum TSAT <50%, and serum phosphorus ≥2.5 and ≤8.0 mg/dL at the screening visit. 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.

CKD=chronic kidney disease; TSAT=transferrin saturation; Active Control=sevelamer carbonate and/or calcium acetate.


EXPLORE SAFETY PROFILE


IMPORTANT SAFETY INFORMATION AND INDICATION

CONTRAINDICATION

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

ADVERSE REACTIONS
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%)

SPECIFIC POPULATIONS

  • 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

INDICATION

AURYXIA® (ferric citrate) is indicated for:

  • The control of serum phosphorus levels in adult patients with chronic kidney disease on dialysis

To report suspected adverse reactions, contact Akebia Therapeutics, Inc. at 1-844-445-3799

Please see full Prescribing Information

REFERENCES

  1. AURYXIA [package insert]. Cambridge, MA: Akebia Therapeutics, Inc.; 2021.
  2. Data on File 1, Akebia Therapeutics, Inc.
  3. 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.
  4. Data on File 29, Akebia Therapeutics, Inc.
  5. Data on File 30, Akebia Therapeutics, Inc.