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Introduction: This study aimed to investigate the efficacy and safety of sucroferric oxyhydroxide (SFOH) versus sevelamer carbonate in controlling serum phosphorus (sP) in adult Chinese dialysis patients with hyperphosphataemia (sP >1.78 mmol/L)., Methods: Open-label, randomised (1:1), active-controlled, parallel group, multicentre, phase III study of SFOH and sevelamer at starting doses corresponding to 1,500 mg iron/day and 2.4 g/day, respectively, with 8-week dose titration and 4-week maintenance (NCT03644264). Primary endpoint was non-inferiority analysis of change in sP from baseline to week 12. Secondary endpoints included sP over time and safety., Results: 415 patients were screened; 286 were enrolled and randomised (142 and 144 to SFOH and sevelamer, respectively). Mean (SD) baseline sP: 2.38 (0.57) and 2.38 (0.52) mmol/L, respectively. Mean (SD) change in sP from baseline to week 12: - 0.71 (0.60) versus -0.63 (0.52) mmol/L, respectively; difference (sevelamer minus SFOH) in least squares means (95% CI): 0.08 mmol/L (-0.02, 0.18) with the lower limit of 95% CI above the non-inferiority margin of -0.34 mmol/L. The SFOH group achieved target sP (1.13-1.78 mmol/L) earlier than the sevelamer group (56.5% vs. 32.8% at week 4) and with a lower pill burden (mean 3.7 vs. 9.1 tablets/day over 4 weeks of maintenance, respectively). Safety and tolerability of SFOH was consistent with previous studies, and no new safety signals were observed., Conclusion: SFOH effectively reduced sP from baseline and was non-inferior to sevelamer after 12 weeks of treatment but had a lower pill burden in Chinese dialysis patients with hyperphosphataemia; SFOH benefit-risk profile is favourable in Chinese patients., (© 2023 The Author(s). Published by S. Karger AG, Basel.)

Aims: High serum phosphorus levels are a common problem in patients receiving long-term dialysis treatment. Lanthanum carbonate (Fosrenol®) is a new nonaluminum, non-calcium phosphate binder developed for the treatment of hyper phosphatemia in patients with end-stage renal disease (ESRD). We report data from a recent trial, which, for the first time, assessed the efficacy and tolerability of lanthanum carbonate treatment, compared with placebo, in Chinese patients with ESRD. Patients and methods: Following a one- to three-week wash out phase and a four-week, open-label lanthanum carbonate dose-titration phase, male and female hemodialysis patients were randomized (1:1) to receive either lanthanum carbonate or placebo for four weeks. The primary efficacy parameter of the study was the control of serum phosphorus levels (≤ 1.8 mmol/l [≤ 5.6 mg/dl]). Secondary end points included the profile of serum phosphorus during titration and parathyroid hormone, calcium, and calcium × phosphorus (Ca × P) product levels. The safety and tolerability of lanthanum carbonate were assessed by monitoring adverse events throughout the study. Results: Mean serum phosphorus level at the end of washout was 2.5 ± 0.5 mmol/l (7.7 ± 1.5 mg/dl; n = 73), and there was no evidence of a difference in levels between the treatment groups pre-randomization. At the end of the study, lanthanum carbonate-treated patients had significantly lower phosphorus levels (1.6 ± 0.5 mmol/l [5.1 ± 1.5 mg/dl]; n = 30) than those receiving placebo (2.3 ± 0.4 mmol/l [7.2 ± 1.3 mg/dl]; n = 31; p < 0.001). In addition, a significantly higher proportion of patients receiving lanthanum carbonate had con trolled serum phosphorus levels (60%) compared with the placebo group (10%; p < 0.001). Ca × P product levels were also significantly lower in the lanthanum carbonate group at the end of randomized treatment (p < 0.001). Lanthanum carbonate was well tolerated; only one serious adverse event was reported, which was unrelated to treatment. Conclusions: Lanthanum carbonate was shown to be an effective and well-tolerated phosphate binder for the treatment of hyperphosphatemia in Chinese patients with ESRD. This finding supports the results of previous US and European studies, which have also shown that lanthanum carbonate treatment effectively controls serum phosphorus levels. [ABSTRACT FROM AUTHOR]

BACKGROUND Sevelamer is an effective calcium-free phosphate binder, but widespread use of this agent is restricted by its considerable expense. OBJECTIVE To ascertain whether there is a more cost-effective way of prescribing sevelamer in patients on peritoneal dialysis than the current 'treat to goal' approach. DESIGN Adults who were receiving peritoneal dialysis and had a serum calcium-phosphorus product >4.4 mmol²/l² [>55 mg²/dl²]) were recruited for this open-label study at the Prince of Wales Hospital in Hong Kong. Previous use of sevelamer was an exclusion criterion. INTERVENTION Patients were randomized on a 1:2 basis to receive either 4.0 g/day sevelamer (the maximum recommended dose) or a low dose of 1.2 g/day, both given in divided doses with food. Use of vitamin D analogs and calcium-based or aluminum-based phosphate binders was not restricted. Follow-up continued for 6 months, with assessments at 4 weeks, 8 weeks and every 8 weeks thereafter. OUTCOME MEASURE The primary end point was the proportion of patients whose serum calcium-phosphorus product declined to the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) target of <4.4 mmol²/l² (<55 mg²/dl²). RESULTS A total of 27 patients underwent randomization (9 to the conventional sevelamer dose; 18 to the low dose); all were of Chinese ethnicity. The patients' mean age was 54 ± 14 years, and the mean baseline serum calcium-phosphorus product was 5.7 mmol²/l² (71 mg²/dl²). There were no significant differences in demographic, clinical or laboratory characteristics between the two groups at baseline. The dose of phosphate binders did not change significantly in either group during the study. Adherence to sevelamer treatment was 90% in the conventional- dose group and 89% in the low-dose group. The incidence of adverse events (both overall and serious) was comparable in the two groups. During the 6 months of the study, serum calcium-phosphorus product declined significantly in the 4.0 g/day group, but not in the 1.2 g/day group (-1.9 mmol²/l² [-23.5 mg²/dl²], P=0.003, and -0.3 mmol²/l² [-3.7 mg²/dl²], P=0.28, respectively). Multivariate analysis identified only serum calcium-phosphorus product at 1 month as a predictor of sevelamer response at 6 months (P= 0.006). After 6 months of sevelamer treatment, the difference in the primary end point between the patients randomized to the conventional sevelamer dose and those randomized to the low dose was not significant (66.7% vs 33.3%; P=0.10). The number of patients needed to treat to achieve the KDOQI target for serum calcium-phosphorus product in 1 individual would be 1.5 with 4.0 g/day sevelamer and 3 with 1.2 g/day sevelamer. Using a daily sevelamer dose of 1.2 g/day instead of 4.0 g/day would enable an extra 66.7% of patients to attain this target, at a saving of US$201 per patient for 6 months' treatment. CONCLUSION Low-dose sevelamer treatment might control serum calcium-phosphorus product more cost-effectively than conventional dosing in patients on peritoneal dialysis. [ABSTRACT FROM AUTHOR]