Abstract
Abstract 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.
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