Kidney Week

Abstract: FR-PO763

Safety and Effectiveness of Sucroferric Oxyhydroxide in Dialysis Patients: 24-Month Interim Analysis of the VERIFIE Study

Session Information

• Dialysis: Inflammation and Infection
  October 26, 2018 | Location: Exhibit Hall, San Diego Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Dialysis

• 701 Dialysis: Hemodialysis and Frequent Dialysis

Authors

• Ketteler, Markus, Klinikum Coburg GmbH, Coburg, Germany

Markus Ketteler,

• Boletis, John, Laiko University Hospital, Athens, Greece

John Boletis,

• De Francisco, Angel Luis M., Hospital Univ. Marques de Valdecilla, Santander, CTB, Spain

Angel Luis M. De Francisco,

• Vervloet, Marc G., VU university medical centre, Overveen, Netherlands

Marc G. Vervloet,

• Kalra, Philip A., Salford Royal Hospital NHS Trust, Salford, United Kingdom

Philip A. Kalra,

• Fouque, Denis, University Claude Bernard, Pierre Benite, France

Denis Fouque,

• Messa, Piergiorgio, Maggiore Hospital, Milan, Italy

Piergiorgio Messa,

• Stauss-Grabo, Manuela, Fresenius Medical Care, Bad Homburg, Germany

Manuela Stauss-Grabo,

• Derlet, Anja, Fresenius Medical Care, Bad Homburg, Germany

Anja Derlet,

• Rakov, Viatcheslav, Vifor Fresenius Medical Care Renal Pharma, Glattbrugg, Switzerland

Viatcheslav Rakov,

• Walpen, Sebastian, Vifor Fresenius Medical Care Renal Pharma, Glattbrugg, Switzerland

Sebastian Walpen,

• Ficociello, Linda, Fresenius Medical Care Renal Therapies Group, Waltham, Massachusetts, United States

Linda Ficociello,

• Rottembourg, Jacques B., Groupe Hospitalier Pitié-Salpêtrière, Paris, France

Jacques B. Rottembourg,

• Wanner, Christoph, University Hospital, Wuerzburg, Germany

Christoph Wanner,

• Cannata-Andia, Jorge B., Hospital Universitario Central de Asturias, Oviedo, Spain

Jorge B. Cannata-Andia,

Background

Sucroferric oxyhydroxide (SFOH) is an iron-based phosphate binder (PB) for the treatment of hyperphosphatemia in dialysis patients (pts).

Methods

VERIFIE is a non-interventional prospective, multicenter, European cohort study evaluating the real-world safety and effectiveness of SFOH. This interim analysis was performed 24 months after first-patient, first-visit.

Results

1075 pts (mean age 61.5 yrs; 66.7% male) were included in the safety analysis set, with 1023 pts in the full analysis set to evaluate SFOH effectiveness. Prior PB use was reported for 58.9% of pts at study entry, while 40.1% received concomitant PBs during the study. The mean observation period was 186 days. In total, 378 (35.2%) pts reported ≥1 adverse drug reaction, the vast majority of which were gastrointestinal-related (Panel A). 263 (24.5%) pts withdrew from the study during the observation period. No statistically significant changes in serum ferritin, TSAT or hemoglobin were observed from baseline (BL) to Month 18. Mean daily dose of SFOH during observation period was 1144.3 mg (2.3 pills/day). Overall, serum phosphorus (sP) levels decreased significantly from 6.3 mg/dL at BL to 5.4 mg/dL at Months 6, 12 and 18 with SFOH therapy (p≤0.0001). The % of pts achieving sP control (≤5.5 mg/dL) from BL to Month 6 increased across all participating countries (Panel B).

Conclusion

The safety profile of SFOH was comparable to that observed in the Phase 3 study; no new safety signals were identified. SFOH effectively reduced and maintained sP levels, with a relatively low pill burden.

Funding

• Commercial Support –