Sucroferric oxyhydroxide monotherapy for hyperphosphatemia in Indian chronic kidney disease patients undergoing hemodialysis:A phase IV,single-arm,open-label study  

作　　者：M R Niranjan Sanjay Srinivasa Vibhanshu Gupta Anil K Bhalla Ankush Gaikwad Prajakta Wangikar Sachin Suryawanshi Priti Gajbe 

机构地区：[1]Department of Nephrology,Mysore Medical College and Research Institute,Mysore 570001,Karnātaka,India [2]Department of Nephrology,Dr.Sanjay’s Center for Kidney and Diabetes,Bengaluru 560064,Karnātaka,India [3]Department of Nephrology,Pushpanjali Hospital and Research Centre,Agra 282002,Uttar Pradesh,India [4]Department of Nephrology,Sir Ganga Ram Hospital,New Delhi 110060,Delhi,India [5]Department of Medical Services,Emcure Pharmaceuticals Ltd,Mumbai 400072,Mahārāshtra,India

出　　处：《World Journal of Nephrology》2025年第2期105-113,共9页世界肾病学杂志(英文)

摘　　要：BACKGROUND Hyperphosphatemia(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™)is a calcium-free,polynuclear iron(III)based oral phosphate binder,for the treatment of HP.In this phase IV,open-label,singlearm,multi-center,12-week,SOLO CKD study evaluated efficacy and safety of Dynulta™in Indian CKD patients undergoing hemodialysis.AIM To investigate the efficacy,safety and tolerability of SO Chewable Tablet(Dynulta™)in patients with CKD on hemodialysis.METHODS Hyperphosphatemic 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 P<0.05 considered statistically significant,using Graph Pad software.RESULTS A 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(P value<0.05)compared to baseline,confirming the efficacy of SO.A total of 33.33%of patients experienced adverse events(AEs).The most frequently reported AEs were pyrexia,nasopharyngitis and headache,which were considered unlikely to be related to the study drug treatment.No serious AEs was reported during the study period and no patients discontinued treatment due to AEs.CONCLUSION This 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.

关 键 词：Chronic kidney disease Dynulta™ HEMODIALYSIS HYPERPHOSPHATEMIA Iron-based phosphate binder Sucroferric oxyhydroxide 

分 类 号：R692[医药卫生—泌尿科学]