Trial reportWorld journal of nephrology2025
Sucroferric oxyhydroxide monotherapy for hyperphosphatemia in Indian chronic kidney disease patients undergoing hemodialysis: A phase IV, single-arm, open-label study.
Trial report in World journal of nephrology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
8 authors.
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Abstract
backgroundHyperphosphatemia (HP) is a common complication in an advanced stage of chronic kidney disease (CKD) and is associated with cardiovascular issues, metabolic bone abnormalities and worsening of secondary hyperparathyroidism. Most patients on dialysis require phosphate binders to control HP. Sucroferric oxyhydroxide (SO) (Dynulta
aimTo investigate the efficacy, safety and tolerability of SO Chewable Tablet (Dynulta
methodsHyperphosphatemic patients on hemodialysis and fulfilling eligibility criteria were included in the study for at least 12 weeks and received SO 1500 mg chewable tablet per day. The key endpoint was change in mean serum phosphorus levels after 12 weeks. Data were analysed using analysis of variance, Paired test, Wilcoxon test, and post-hoc comparisons, with
resultsA total of 114 patients were enrolled and 94 patients completed the study. The mean ± SD serum phosphorous level was reduced from 7.62 mg/dL ± 2.02 mg/dL at baseline to 5.13 mg/dL ± 1.88 mg/dL after 12 weeks of treatment. At each follow-up visit, the reduction in mean serum phosphorous levels was statistically significant (
conclusionThis first real-world study in Indian CKD patients on hemodialysis shows SO as a safe, and effective monotherapy for HP, though its small sample size limits generalizability.
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