Date: 2015-03-04
Type of information: Publication of results in a medical journal
phase: 3
Announcement: publication of results in the Journal of the American Society of Nephrology
Company: Keryx Biopharmaceuticals (USA - NY)
Product: Fexeric®/Auryxia™ (ferric citrate coordination complex)
Action
mechanism: Auryxia™/Fexeric® (ferric citrate) binds with dietary phosphate in the GI tract and precipitates as ferric phosphate. The unbound portion of Auryxia/Fexeric® has been shown to increase serum iron parameters including ferritin and transferrin saturation, whereas these parameters remained relatively constant in patients treated with active control. Iron absorption from Auryxia may lead to excessive elevations in iron stores. Accordingly, physicians should assess and monitor iron parameters before starting and while on Auryxia, and may need to decrease or discontinue IV iron for these patients.
Disease: hyperphosphataemia in adult patients with chronic kidney disease
Therapeutic area: Kidney diseases - Metabolic diseases - Renal diseases
Country:
Trial details:
Latest
news: * On March 4, 2015, Keryx Biopharmaceuticals announced the publication of Auryxia™ (ferric citrate) data and expert analyses in two peer-reviewed journals. An analysis of the effect of Auryxia™ on intravenous (IV) iron and erythropoiesis-stimulating agent (ESA) dosage and utilization was published online in the Journal of the American Society of Nephrology (JASN). Auryxia™ was approved by the FDA in September 2014 for the control of serum phosphorus levels in chronic kidney disease (CKD) patients on dialysis. The publication in JASN, titled "Ferric Citrate Reduces Intravenous Iron and Erythropoiesis-Stimulating Agent Use in ESRD" was led by Kausik Umanath, MD, Division of Nephrology and Hypertension at Henry Ford Hospital. The analysis was based on the Phase 3 long-term safety and efficacy trial of Auryxia in dialysis-dependent CKD patients. The primary data from this study was published in 2014 in the Journal of the American Society of Nephrology. Separately, an expert analysis was also recently published online in Expert Review of Pharmacoeconomics & Outcomes Research. The review titled "Phosphorus Binding with Ferric Citrate Is Associated with Fewer Hospitalizations and Reduced Hospitalization Costs" was published online in Expert Review of Pharmacoeconomics & Outcomes Research and was led by Roger A. Rodby, MD, Division of Nephrology, Rush University Medical Center. This post-hoc analysis was based on the Phase 3 long-term safety and efficacy trial of Auryxia in dialysis-dependent chronic kidney disease patients.
