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.

BACKGROUND AND AIMS Currently, the effectiveness of phosphate-binding agents in patients with CKD should be determined not only by the level of reduction in hyperphosphatemia, but also by the effect on other key factors involved in the development of CKD-MBD. The results of the effect of phosphate binders on the parameters of CKD-MBD, excluding phosphate, are unclear. Our prospective randomized controlled trial evaluated the effect of 16-week treatment with sucroferric oxyhydroxide versus sevelamer carbonate (‘sevelamer’) on the parameters of CKD-MBD in patients with hyperphosphatemia on programmed hemodialysis. METHOD A total of 50 stable patients with hyperphosphatemia (P ˃ 5.5 mg/dL) after a 4-week washout period, 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 monthly evaluated levels of FGF23, soluble Klotho, c-reactive protein (CRP), hemoglobin (Hb), ferritin, transferrin saturation, phosphorus (P), calcium (Ca), parathyroid hormone (PTH). The dose of both medications was adjusted according to serum phosphate. RESULTS The average intact fibroblast growth factor 23 (FGF23), PTH, transferrin saturation and ferritin levels did not significantly change in both groups. Meanwhile, Klotho levels increased by 25% in the sucroferric oxyhydroxide group (P < 0.05). We observed a significant decrease in serum phosphate level from 6.8 ± 1.5 to 5.27 ± 0.99 mg/dL (P < 0.01) only in the group with sucroferric oxyhydroxide. However, treatment with sevelamer did not decrease the level of P: 6.32 ± 1.5 versus 6.35 ± 1.9 mg/dL by the end of the study. The number of prescribed tablets was lower in the sucroferric oxyhydroxide group (2.0 ± 1.5 tab/day, mean ± SD) compared with sevelamer group (6.1 ± 3.2 tab/day, mean ± SD). We noted also in group sucroferric oxyhydroxide an increased Hb level from 105.6 ± 15.7 to 111.9 ± 22.3 g/L (P < 0.05) and a simultaneous decrease of CRP level by 50% (P < 0.01). CONCLUSION Treatment with sucroferric oxyhydroxide significantly increased Klotho and Hb levels and lowered CRP levels. Sucroferric oxyhydroxide was more effective in lowering phosphorus levels than sevelamer, which can be explained by an insufficient dose of sevelamer and a short treatment period.

Background and Aims The treatment of secondary hyperparathyroidism is one of the main tasks in the correction of mineral and bone disorders (MBD) in patients with chronic kidney disease (CKD). However, the results of therapy for secondary hyperparathyroidism are still unsatisfactory. In our prospective randomized controlled trial were evaluated the effect and safety of 26 weeks of treatment with etelcalcetide (intravenous route of administration) compare with cinacalcet (oral administration) on CKD-MBD parameters in patients on program hemodialysis with secondary hyperparathyroidism. Method The study group included 50 stable patients receiving hemodialysis with secondary hyperparathyroidism (PTH > 300 pg/ml) and corrected Ca level greater than 2.2 mmol/L, who were randomized in a 1: 1 ratio for treatment with etelcalcetide (n = 25) or cinacalcet (n = 25) for 26 weeks. All patients were monthly evaluated the levels of P, Ca, intact parathyroid hormone (iPTH), alkaline phosphatase (ALP); the levels of FGF 23, Klotho protein and sclerostin were assessed once in 3 months. The dose of both drugs was adjusted according to the serum iPTH level. The nature, frequency, and severity of treatment-emergent adverse events were assessed. Results Therapy with cinacalcet and etelcalcetide led to a significant decrease in the level of iPTH in the blood serum from 613.1 ± 235.1 to 302.2 ± 205.1pg/ml (p< 0.01) and from 671.2 ± 272.3 to 358,6 ± 292.5 pg/ml (p <0.01), by 49.2% and 53.4%, respectively. A significant decrease in the levels of corrected Ca was noted in both groups: in the etelcalcetide group from 2.20 ± 0.12 to 2.06 ± 0.18 mmol/L (p <0.05), in the cinacalcet group from 2.25 ± 0.12 to 2.04 ± 0.21 mmol/l (p <0.05). There was no significant change in the P levels. The alkaline phosphatase level significantly decreased in the cinacalcet group from 178.7 ± 116.8 to 78.9 ± 34.1 U/L, p <0.05) and in the etelcalcetide group from 170,3 ± 115.7 to 87.1 ± 30.8 U/L, p <0.05. There was a significant increase in Klotho protein levels by the end of the study from 17.9 ± 5.0 to 57.1 ± 39.3 (p <0.05) and from 17.6 ± 3.7 to 91.6 ± 56.2 pg/ml (p <0.05), respectively, in the cinacalcet and etelcalcetide group. Changes in FGF-23 and sclerostin by 6 months reached statistically significant changes only in the etelcalcetide group, a decrease from the FGF-23 level from 42.7 ± 22.2 to 23.0 ± 12.3 pg/ml and an increase in the level of sclerostin from 1, 59 ± 0.31 to 2.20 ± 0.33 ng/ml (p <0.05). During the study, 2 patients in the cinacalcet group dropped out due to dyspeptic symptoms and 1 patient in the etelcalcetide group dropped out due to hypocalcemia. Conclusion Etelcalcetide and cinacalcet are effective PTH-lowering drugs with a comparable safety profile. Treatment with etelcalcetide, in contrast to cinacalcet, was associated with significant increases in sclerostin and decreases in FGF-23, which may have beneficial effects on outcomes and requires further study.

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