The first and only oral iron specifically indicated for adults with CKD-NDD

Discover the Hb and iron parameter results for AURYXIA from the 16-week pivotal trial.1-4

CKD=chronic kidney disease; NDD=non-dialysis dependent.

AURYXIA increased Hb ≥ 1.0 g/dL in the majority of treated patients1

Primary endpoint

Proportion of patients achieving an Hb increase of ≥ 1.0 g/dL at any time by Week 16

Primary endpointPrimary endpoint

All efficacy endpoints were achieved without ESA or IV iron use, per exclusion criteria and study design.

Summary of change in Hb (g/dL) from baseline over time during
randomized period based on observed values3

FERRIC CITRATEPLACEBO
 Mean Hb
(g/dL)
Mean Hb
(g/dL)
Change from Baseline
(P-Value)
Baseline
(n)
10.44
(117)
10.38
(115)
Week 1
(n)
10.45
(110)
10.25
(107)
0.11 (0.07)
Week 2
(n)
10.55
(114)
10.28
(103)
0.24 (0.001)
Week 4
(n)
10.68
(108)
10.33
(100)
0.33 (<0.001)
Week 6
(n)
10.81
(102)
10.29
(96)
0.49 (<0.001)
Week 8
(n)
10.98
(97)
10.39
(91)
0.57 (<0.001)
Week 10
(n)
11.06
(97)
10.37
(88)
0.69 (<0.001)
Week 12
(n)
11.16
(97)
10.44
(85)
0.69 (<0.001)
Week 14
(n)
11.25
(97)
10.42
(85)
0.81 (<0.001)
Week 16
(n)
11.41
(97)
10.51
(77)
0.84 (<0.001)

AURYXIA increased mean hemoglobin levels over 16 weeks of treatment2,3

Proven efficacy in CKD-NDD: 52% of patients treated with AURYXIA achieved an Hb increase of ≥ 1.0 g/dL at any time point by Week 161 (P<0.001)

Key secondary endpoint: Mean Hb increase from 10.4 g/dL to 11.4 g/dL by the end of the 16-week period2,3

AURYXIA (n=117)

PLACEBO (n=115)

Key secondary endpointKey secondary endpoint
  • No IV iron or ESA use, as per trial design and exclusion criteria1
  • Studied in patients who were unsuccessful with or intolerant of traditional oral iron therapy1*

AURYXIA increased TSAT and ferritin over 16 weeks of treatment2

Key secondary endpoint: Mean change in TSAT over time4

AURYXIA (n=117)

PLACEBO (n=115)

Key secondary endpoint

Over 16 weeks, AURYXIA increased mean TSAT from 20.2% to 35.6%4

(P<0.001)

Key secondary endpoint: Mean change in ferritin over time

AURYXIA (n=117)

PLACEBO (n=115)

Key secondary endpoint

Over 16 weeks, AURYXIA increased mean ferritin from 85.9 ng/mL to 233.5 ng/mL5

(P<0.001)

(P<0.001)

(P<0.001)

  • Patients on AURYXIA also achieved a mean increase in serum ferritin of 163 ng/mL from baseline (85.9 ng/mL) at Week 161,2
  • No use of IV iron or ESAs, as per trial design and exclusion criteria1
  • Studied in patients who were unsuccessful with or intolerant of traditional oral iron therapy1

Trial design1

In a 24-week study consisting of a 16-week, randomized, double-blind, placebo-controlled efficacy period followed by an 8-week, open-label safety extension period, this trial evaluated the efficacy and safety of AURYXIA for the treatment of iron deficiency anemia in adult patients with CKD not on dialysis. Patients who were intolerant of or have had an inadequate therapeutic response to oral iron supplements, with hemoglobin ≥9.0 g/dL and ≤11.5 g/dL, serum ferritin ≤200 ng/mL, and TSAT ≤25% were enrolled. Patients were randomized to treatment with either AURYXIA (n=117) or placebo (n=117).

The primary endpoint was the proportion of patients achieving a ≥1.0 g/dL increase in hemoglobin at any time point during the 16-week efficacy period. Use of oral iron, IV iron, or ESAs was not permitted at any time during the trial.

Key secondary endpoints included:

  • Mean changes in hemoglobin, TSAT, ferritin, and phosphorus from baseline to Week 16
  • Proportion of patients experiencing a sustained treatment effect on hemoglobin (≥0.75 g/dL mean change from baseline over any 4-week period provided that an increase of at least 1.0 g/dL had occurred during that 4-week period)

CKD=chronic kidney disease; Hb=hemoglobin; IV=intravenous; ESAs=erythropoiesis-stimulating agents; TSAT=transferrin saturation.

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:

  • Iron Deficiency Anemia in CKD Not on Dialysis: Discolored feces (22%), diarrhea (21%), constipation (18%), nausea (10%), abdominal pain (5%) and hyperkalemia (5%)

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 treatment of iron deficiency anemia in adult patients with chronic kidney disease not 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. Fishbane S, Block GA, Loram L, et al. Effects of ferric citrate in patients with nondialysis-dependent CKD and iron deficiency anemia. J Am Soc Nephrol. 2017;28(6):1851-1885.
  3. Data on File 16, Akebia Therapeutics, Inc.
  4. Data on File 14, Akebia Therapeutics, Inc.
  5. Data on File 17, Akebia Therapeutics, Inc.
  6. Data on File 24, Akebia Therapeutics, Inc.