Abstract: FR-PO886

Evaluating the Real-World Safety and Effectiveness of Sucroferric Oxyhydroxide in Dialysis Patients: An Interim Analysis of the VERIFIE Study

Session Information

Category: Dialysis

  • 607 Dialysis: Epidemiology, Outcomes, Clinical Trials - Non-Cardiovascular

Authors

  • Vervloet, Marc G., VU University Medical Centre, 2051 JN Overveen, Netherlands
  • Walpen, Sebastian, Vifor Fresenius Medical Care Renal Pharma, Glattbrugg, Switzerland
  • Ficociello, Linda H., Fresenius Medical Care - North America, Waltham, Massachusetts, United States
  • Rottembourg, Jacques B., Groupe Hospitalier Pitié-Salpêtrière, Paris, France
  • Wanner, Christoph, University Hospital of Würzburg, Wuerzburg, Germany
  • Cannata-Andia, Jorge B., Hospital Universitario Central de Asturias, Oviedo, Spain
  • Boletis, John N, Laiko University Hospital, Athens, Greece
  • De Francisco, Angel Luis M., Marques de Valdecilla University Hospital, Santander, Spain
  • Fouque, Denis, University Claude Bernard, Pierre Benite, France
  • Kalra, Philip A., Salford Royal Hospital NHS Trust, Salford, United Kingdom
  • Ketteler, Markus, Coburg Clinic and KfH-Dialysis Center, Coburg, Germany
  • Messa, Piergiorgio, Maggiore Hospital, Milan, Italy
  • Stauss-Grabo, Manuela, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Germany
  • Rakov, Viatcheslav, Vifor Fresenius Medical Care Renal Pharma, Glattbrugg, Switzerland
Background

Sucroferric oxyhydroxide (SFOH) is a non-calcium-, iron-based phosphate binder. The VERIFIE study aims to investigate the real-life safety and effectiveness of SFOH in prevalent dialysis patients with hyperphosphatemia.

Methods

This is a non-interventional, prospective, multicenter, European cohort study (scheduled observation period per patient: 12–36 months; planned enrollment: 1000 patients). The non-interventional design allows the observation of patients in a broad range of settings reflecting routine clinical practice. SFOH initiation was based on the physician’s decision and was not influenced by study inclusion.

Results

This interim analysis presents data from 244 patients (mean age: 63.8 [standard deviation: 14.7] years; 64.0% male) included in the safety analysis set, of whom 219 were included in the full analysis set for the evaluation of laboratory parameters (serum ferritin and serum phosphorus). The mean observation period was 129 days. Phosphate binder use at baseline was reported in 64% of patients, mostly sevelamer (55%), calcium-based (39%) or lanthanum (34%). Mean initial dose of SFOH was 1175.4 mg (2.4 pills/day), rising to 1299.4 mg (2.6 pills/day) at the time of this analysis. The large majority of adverse drug reactions reported were gastrointestinal (Table). Serum phosphorus decreased from baseline to last visit by a mean of 0.8 mg/dL (p<0.0001). Serum ferritin levels were not significantly different from baseline by the last visit (p=0.23).

Conclusion

These interim real-world data show that SFOH is well tolerated, and no new safety risks were identified. In addition, SFOH was effective at reducing serum phosphorus in real-world practice.

Funding

  • Veterans Affairs Support