P1411THE EFFICACY AND SAFETY OF THE SUCROFFERRIC OXYHYDXIDE IN HEMODIALYSIS PATIENTS : RESULTS OF A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL

Abstract

Abstract Background and Aims The treatment of hyperphosphatemia is the main goal in the treatment of mineral and bone disorders in patients with CKD. However, the results of the correction of hyperphosphatemia remain unsatisfactory. This is due to the absence of effective and safe medicines. In our prospective randomized controlled trial were evaluated the effects of a 16-week treatment with new phosphate binder - sucroferric oxyhydroxide and a sevelamer carbonate (“sevelamer”) on CKD-MBD parameters in patients on hemodialysis with hyperphosphatemia. Method After a 2-4-week washout period from previous phosphate binders, 50 stable patients with hyperphosphatemia (P > 5.5 mg / dl) were randomized at a 1: 1 ratio to receive sucroferric oxyhydroxide (n = 25) or sevelamer (n = 25) for treatment up to 16 weeks. In all patients were evaluated levels of P, Ca, PTH, ferritin, transferrin saturation, Hb, FGF-23, soluble Klotho, CRP - monthly. The dose of both medications was adjusted according to serum phosphate. Results Phosphate binder therapy of sucroferric oxyhydroxide was associated with a significant decrease in serum phosphate from 6.8 ± 1.5 to 5.27 ± 0.99 mg/dl (p <0.01); however, treatment with sevelamer did not decrease in the level of P: 6.32 ± 1.5 vs 6.35 ± 1.9 mgl/dl. The number of tablets was lower in the sucroferric oxyhydroxide group (mean ± SD 2.0 ± 1.5 tablets / day) compared with sevelamer (mean ± SD 6.1 ± 3.2 tablets / day). The average intact fibroblast growth factor-23 (FGF-23), PTH, transferrin saturation and ferritin did not significantly change in both groups. Klotho changed only in patients received sucroferric oxyhydroxide, an increase of 25% (р < 0.05) and we also noted in this group an increase in Hb level from 105.6 ± 15.7 to 111.9 ± 22.3 g/l (p <0.05) by the end of the study, simultaneously level of CRP significantly decreased (P < 0.01) by 50% . During the study, 6 patients in the group with sucroferric oxyhydroxide and 5 in the sevelamer group dropped out due to dyspeptic symptoms. Conclusion Sucroferric oxyhydroxide is a new effective phosphate binder with a comparable safety profile to a sevelamer. Treatment with this drug can significantly increase the level of Hb, and Klotho and reduce level of inflammation.