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
- 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
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.
- Data on File 10, Akebia Therapeutics, Inc.
- Data on File 3, Akebia Therapeutics, Inc.
- 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.
- Data on File 11, Akebia Therapeutics, Inc.
- Data on File 6, Akebia Therapeutics, Inc.