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Kidney Week

Abstract: TH-PO973

Hospitalizations and Red Blood Cell (RBC) Transfusions in Patients with Dialysis-Dependent-CKD (DD-CKD) on Auryxia® Compared with Other Phosphate Binders

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Authors

  • Newby, F. David, Nephrology and Hypertension Specialists, PC, Dalton, Georgia, United States
  • Broumand, Varshasb, South Texas Renal Care Group, San Antonio, Texas, 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 (DD-CKD). Primary efficacy results of this study of Auryxia as phosphorus lowering therapy compared to standard of care (SOC) in patients with CKD undergoing dialysis showed a statistically significant reduction in erythropoiesis-stimulating agents (ESAs) and a reduction in intravenous (IV) iron. Here, we further explore hospitalizations and red blood cell (RBC) transfusions.

Methods

This open-label, active-controlled, multicenter study (NCT04922645), in subjects receiving ESA and either in-center or home dialysis, were randomized 1:1 to receive Auryxia or remain on SOC phosphorus-lowering therapy for up to 6 months. Dose adjustments were at investigator discretion to achieve target serum phosphorus. The primary endpoint was the 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. Safety and exploratory analyses estimated the rate of hospitalizations, hospital days, RBC transfusion, and units of packed red blood cells (PRBC) per person-month from day 1 through the end of study.

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. Hospitalization event rates per 100 person-months were 7.4and 10.6 in the Auryxia (40 events) and SOC (63 events) treatment groups, respectively. Subjects in the Auryxia group had 60 hospitalization days per 100 person-months compared to 82.6 days in the SOC group. RBC transfusion rates per 100 person-months were 1.5 and 4.2 in the Auryxia (8 events) and SOC (25 events) treatment groups, respectively. The rates of PRBC transfusions, per 100 person-months were 2.4 and 7.1 with Auryxia (13 units) and SOC (42 units), respectively.

Conclusion

Treatment with Auryxia as compared to remaining on SOC phosphate binders resulted in lower hospitalization rates, fewer hospitalization days, fewer RBC transfusions and fewer PRBC units used.

Funding

  • Commercial Support – Akebia