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SAFETY

AURYXIA® (ferric citrate) demonstrated safety over the 52-week pivotal trial

Fewer patients on AURYXIA (41.9%) experienced serious adverse events (SAEs) compared to patients taking sevelamer carbonate and/or calcium acetate (49.7%)1

  • SAEs occurring in ≥2% of patients treated with AURYXIA included renal transplant (4.5%),
    chest pain (3.8%), pneumonia (2.8%), fluid overload (2.1%), gastrointestinal hemorrhage (2.1%), and hypotension (2.1%)1
  • SAEs occurring in ≥2% of patients treated with Active Control included sepsis (5.4%), chest pain (3.4%), fluid overload (3.4%), hypertension (3.4%), renal transplant (3.4%), acute myocardial infarction (2.7%), dyspnea (2.7%), hypotension (2.7%), pneumonia (2.7%), bacteremia (2.0%), cardiac failure congestive (2.0%), coronary artery disease (2.0%), deep vein thrombosis (2.0%), gastroenteritis (2.0%), pulmonary edema (2.0%), pulmonary embolism (2.0%), rectal hemorrhage (2.0%), respiratory failure (2.0%), vascular access complication (2.0%), and vomiting (2.0%)1

 

There were no reported cases of iron overload associated with AURYXIA during the trial

 

AURYXIA demonstrated tolerability over the 52-week pivotal trial2

For patients on AURYXIA, the most common adverse event was diarrhea (25.6%), the majority of which was defined as mild to moderate in severity3

AURYXIA_Chart1-01

  • 21% of patients on AURYXIA and 14% of those on active control discontinued treatment over 52 weeks because of an adverse reaction. Gastrointestinal (GI) adverse reactions were the most common reason for discontinuing AURYXIA (14%)
  • Patients with inflammatory bowel disease or actively symptomatic GI bleeding were excluded from clinical trials
  • In a pooled safety analysis of this pivotal Phase III trial and 3 short-term trials, the majority of diarrhea resolved within 2 weeks from onset4

 

STUDY DESIGN

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.