ASN's Mission

ASN leads the fight to prevent, treat, and cure kidney diseases throughout the world by educating health professionals and scientists, advancing research and innovation, communicating new knowledge, and advocating for the highest quality care for patients.

learn more

Contact ASN

1401 H St, NW, Ste 900, Washington, DC 20005

email@asn-online.org

202-640-4660

The Latest on Twitter

Kidney Week

Abstract: FR-PO149

Phosphate Binder Therapy with Sucroferric Oxyhydroxide Reduces Calcification Propensity in Hemodialysis Patients: Results from a Randomized, Controlled, Crossover Trial

Session Information

Category: Bone and Mineral Metabolism

  • 402 Bone and Mineral Metabolism: Clinical

Authors

  • Cejka, Daniel, Ordensklinikum Linz - Elisabethinen hospital, Linz, Austria
  • Robl, Bernhard, Ordensklinikum Linz - Elisabethinen hospital, Linz, Austria
  • Watorek, Ewa, Ordensklinikum Linz - Elisabethinen hospital, Linz, Austria
  • Blum, Sabine, Ordensklinikum Linz - Elisabethinen hospital, Linz, Austria
  • Dumfarth, Alexandra, Ordensklinikum Linz - Elisabethinen hospital, Linz, Austria
  • Marculescu, Rodrig, Medical University of Vienna, Vienna, Austria
  • Pasch, Andreas, Calciscon AG, Nidau, Switzerland
  • Haller, Maria C., Ordensklinikum Linz - Elisabethinen hospital, Linz, Austria
Background

High calcification propensity (i.e. short T50 times in the calciprotein particle formation test) is associated with a higher risk of cardiovascular events and mortality in ESRD patients. So far, no clinical trial has investigated the effect of lowering serum phosphate with oral phosphate binder therapy on calcification propensity in ESRD patients.

Methods

Single-center, open-label, controlled, randomized, cross-over study in chronic hemodialysis patients with hyperphosphatemia. Patients were randomized in a 1:1 ratio to either low-dose (250mg/d) sucroferric oxyhydroxide (PA21) followed by high-dose (2000mg/d) PA21 or vice versa, with wash-out phases (no phosphate binder therapy) in between. The primary endpoint was change in T50 time between wash-out and high dose PA21 treatment in patients with ≥85% adherence to the prescribed PA21 dose (per protocol analysis). There was no carry-over effect as determined by a linear mixed model, and thus a paired t-test was calculated.

Results

Thirty-nine patients were randomized and 28 patients were available for per-protocol analysis. Compared to phosphate binder wash-out, 2000mg/d PA21 treatment resulted in a mean increase in T50 times of 66 min (95% CI 49-84 min, p<0.0001), from 243 (± 63 min) to 309 (± 74 min). Serum phosphate decreased from 2.28 (± 0.5) to 1.63 (± 0.43) mmol/l. In the secondary intention to treat (ITT) analysis, treatment with 2000 mg/d PA21 resulted in a mean increase in T50 times of 60 min (95% CI 36-83 min, p<0.0001) compared to phosphate-binder wash-out. Serum phosphate decreased from 2.18 +/- 0.5 to 1.64+/- 0.46 mmol/l. In patients achieving a decline in serum phosphate ≥ 0.5 mmol/l between wash-out and the 2000 mg/d treatment phase (N=20, pre-specified subgroup), T50 time increased by 85 min (95% CI 58-112 min, p<0.0001). PA21 at 250 mg/d did not influence T50 times (p=0.4) or serum phosphate values (p= 0.9) compared to phosphate binder wash-out. No major adverse cardiovascular event, case of calciphylaxis or death occurred during the study.

Conclusion

Lowering serum phosphate with PA21 therapy reduces calcification propensity of serum of hemodialysis patients.

Funding

  • Commercial Support