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Kidney Week

Abstract: TH-PO967

Randomized Assessment of Auryxia® Therapy for In-Center and Home Dialysis Patients

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Broumand, Varshasb, South Texas Renal Care Group, San Antonio, Texas, United States
  • Newby, F. David, Nephrology and Hypertension Specialists, PC, Dalton, Georgia, United States
  • Brillhart, Stephanie, US Renal Care, Plano, Texas, United States
  • Block, Martha, US Renal Care, Plano, Texas, United States
  • Leppink, Amanda, US Renal Care, Plano, Texas, United States
  • Danese, Mark D., Outcomes Insights Inc, Calabasas, California, United States
  • Block, Geoffrey A., US Renal Care, Plano, Texas, United States
Background

Auryxia (ferric citrate) is an FDA approved iron-based phosphate binder for adults with dialysis-dependent chronic kidney disease. This study investigated the impact of Auryxia as primary phosphorus lowering therapy on utilization of erythropoiesis-stimulating agent (ESA) and intravenous (IV) iron.

Methods

In this randomized, open-label, active-controlled, multicenter study (NCT04922645), subjects receiving ESA and either in-center hemodialysis or home dialysis were randomized 1:1 to Auryxia (starting dose of 6 tablets per day) or remain on standard of care (SOC) phosphate lowering therapy for up to 6 months. Dose adjustments were at investigator discretion to achieve target serum phosphorus. The primary endpoint was difference in change from baseline (BL, Month -3 to Day 1) to efficacy evaluation period (EEP, Months 4-6) in mean monthly ESA and IV iron doses between groups. Secondary endpoints included difference in proportion with Hb ≥10.0g/dL and serum phosphate ≤5.5 mg/dL.

Results

209 subjects were randomized to Auryxia (n=103) or SOC (n=106). The two groups had generally similar baseline characteristics, although atherosclerotic CV disease and congestive heart failure were more common in the SOC group. During the EEP, the mean treatment difference in ESA administration was -31 mcg/month (p=0.02). A non-statistically significant change in mean monthly IV iron administration of -37 mg/month (p=0.17) was observed. Mean Hb, TSAT, and ferritin all increased from BL to the EEP in the Auryxia vs. SOC group. The proportion of subjects with Hb ≥10.0 g/dL and serum phosphate ≤5.5 mg/dL did not differ between groups. Three subjects stopped Auryxia due to GI intolerance (n=2) or adverse events (n=1). Serious adverse events (SAEs) occurred in 39% of subjects receiving Auryxia vs. 59% in those receiving SOC. No related SAEs were reported. Fewer patients randomized to Auryxia experienced CV (8.7% vs. 13.2%) or infectious (8.7% vs. 17.9%) SAEs.

Conclusion

Treatment with Auryxia as compared to remaining on SOC phosphate binders resulted in increased Hb, increased iron stores, statistically significantly less average monthly ESA use and a non-statistically significant reduction in monthly IV iron use.

Funding

  • Commercial Support – Akebia