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SAFETY AND TOLERABILITY PROFILE EVALUATED IN A 52-WEEK TRIAL

Most common adverse events over the 52-week pivotal trial

For patients on AURYXIA, the most common adverse event was diarrhea (25.6%), the majority of which was defined as mild to moderate in severity1

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%)3
  • Patients with inflammatory bowel disease or actively symptomatic GI bleeding were excluded from clinical trials4
  • In a pooled safety analysis of this pivotal Phase III trial and 3 short-term trials, the majority of diarrhea cases (56%) resolved within 2 weeks from onset5

 

Safety profile of AURYXIA evaluated 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%)6

  • 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%)6
  • 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%)6

 

TRIAL DESIGN3,4

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. 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.