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Kidney Week

Abstract: TH-PO0221

Real-World Effectiveness of Tenapanor (XPHOZAH) for Treatment of Hyperphosphatemia in Patients on Dialysis in the United States

Session Information

Category: Bone and Mineral Metabolism

  • 502 Bone and Mineral Metabolism: Clinical

Authors

  • Fossa, Alan J, Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
  • Sylvertooth, Dhajanae, Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
  • Karaboyas, Angelo, Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
  • Bieber, Brian, Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
  • Pecoits-Filho, Roberto, Arbor Research Collaborative for Health, Ann Arbor, Michigan, United States
  • Rosenbaum, David P., Ardelyx, Inc., Waltham, Massachusetts, United States
  • Williams, Laura, Ardelyx, Inc., Waltham, Massachusetts, United States
  • Scott, Luisa, Ardelyx, Inc., Waltham, Massachusetts, United States
Background

Tenapanor (TEN [XPHOZAH]) is approved to reduce serum phosphorus in adults with chronic kidney disease on dialysis as add-on therapy in patients (pts) who have an inadequate response to phosphate binders (PBs) or who are intolerant of any dose of PBs. This study, the first real-world (RW) study of TEN for management of serum phosphate (P), aimed to characterize RW use and effectiveness of TEN in the US dialysis setting.

Methods

Electronic medical records from pts treated at a mid-size dialysis organization were used to determine within-person change in serum P before vs after TEN initiation. Pts were required to have hyperphosphatemia at baseline (serum P ≥5.5 mg/dL), have a validated TEN prescription, and have ≥1 baseline (30 to 0 days before) and post- (61 to 120 days after) TEN initiation serum P measurement.

Results

The 945 pts analyzed were aged 55 years on average, 61% male, mostly white (47%), and 30% were Hispanic/Latino. Baseline mean serum P (SD) was 7.7 mg/dL (1.6; Figure) and median (Q1, Q3) parathyroid hormone was 498 pg/mL (314, 816). The mean (95% CI) within-patient change in serum P from baseline was −0.93 mg/dL (−1.1, −0.80). In the 61-120 days after TEN initiation, 48% of pts experienced a ≥1-mg/dL reduction in serum P, 29% experienced a ≥2-mg/dL reduction in serum P, and 28% achieved a post-TEN serum P of ≤5.5 mg/dL. Among a subset of patients who were prescribed TEN for ≥120 days (74%; persistent users), results were similar (Figure).

Conclusion

Patients prescribed tenapanor in this real-world study experienced a reduction in serum phosphate of nearly 1 mg/dL on average. These findings support the real-world effectiveness of tenapanor for management of serum phosphate in patients with end stage kidney disease and hyperphosphatemia.

P, phosphate.

Funding

  • Commercial Support – Ardelyx, Inc.

Digital Object Identifier (DOI)