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Efficacy and Safety of Sevelamer Carbonate in Chinese Nondialysis Chronic Kidney Disease Patients with Hyperphosphatemia: A Randomized, Double-Blind, Parallel-Group Study

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机构: [a]Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China [b]Key Laboratory ofNephrology, National Health Commission and Guangdong Province, Guangzhou, China [c]Department of Nephrology,Affiliated Hospital of Guangdong Medical University, Zhanjiang, China [d]Department of Nephrology, The First AffiliatedHospital of Nanchang University, Nanchang, China [e]Department of Nephrology, Peking University First Hospital,Beijing, China [f]Department of Nephrology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,China [g]Department of Nephrology, The Second Xiangya Hospital of Central South University, Changsha, China [h]Department of Nephrology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China [i]Departmentof Nephrology, The Second Hospital of Hebei Medical University, Shijiazhuang, China [j]Department of Nephrology,General Hospital of Ningxia Medical University, Yinchuan, China [k]Department of Nephrology, The Affiliated Hospital ofXuzhou Medical University, Xuzhou, China [l]Department of Nephrology, The First People’s Hospital of Nanning, Nanning,China [m]Department of Nephrology, Hainan General Hospital, Haikou, China [n]Department of Nephrology, SouthwestHospital, Army Medical University, Chongqing, China [o]Department of Nephrology, The Second Hospital of ShanxiMedical University, Taiyuan, China [p]Department of Nephrology, Tianjin People’s Hospital, Tianjin, China [q]Department ofNephrology, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an, China [r]Department of Nephrology, Sun YatsenMemorial Hospital of Sun Yat-sen University, Guangzhou, China [s]Department of Nephrology, The Second AffiliatedHospital of Nanjing Medical University, Nanjing, China [t]Department of Nephrology, The Second People’s Hospital ofYunnan Province, Kunming, China [u]Department of Nephrology and Rheumatology, The Second Hospital, University ofSouth China, Hengyang, China [v]Department of Nephrology, The Third People’s Hospital of Yunnan Province, Kunming,China [w]Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
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关键词: Chronic kidney disease Nondialysis Hyperphosphatemia Phosphate binder Sevelamer carbonate

摘要:
Introduction: Previous studies suggested that sevelamer carbonate is well tolerated with a favorable efficacy and safety profile in both dialysis and nondialysis patients in Europe; however, the efficacy remains controversial, and few studies have examined sevelamer carbonate therapy in other ethnic nondialysis CKD patients. This study assessed the efficacy and safety of sevelamer carbonate in Chinese nondialysis CKD patients with hyperphosphatemia. Methods: The multicenter, randomized, double-blind, parallel group, placebo-controlled, and phase 3 clinical trial enrolled 202 Chinese nondialysis CKD patients with serum phosphorus >= 1.78 mmol/L. Patients were randomly assigned 1:1 to receive sevelamer carbonate (2.4-12 g per day) or placebo for 8 weeks. The primary outcome was the change in serum phosphorous between baseline and week 8. Results: Totally 482 Chinese patients were screened and 202 were randomized (sevelamer carbonate, n=101; placebo, n=101). The mean serum phosphorous decreased significantly in patients treated with sevelamer carbonate compared with placebo (-0.22 +/- 0.47 vs. 0.05 +/- 0.44 mmol/L, p<0.0001). Significantly (p<0.0001) decreases of serum total cholesterol, low-density lipoprotein cholesterol and calcium-phosphorus (Ca x P) product levels from baseline to week 8 were shown in sevelamer carbonate group compared with placebo group. Serum intact parathyroid hormone (iPTH) was not significantly changed in the sevelamer carbonate group (p=0.83). Patients in the sevelamer carbonate group experienced similar adverse events as the placebo group. Conclusion:Sevelamer carbonate is an effective and well-tolerated phosphate binder in advanced nondialysis CKD Chinese patients with hyperphosphatemia.

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出版当年[2023]版:
大类 | 4 区 医学
小类 | 4 区 泌尿学与肾脏学
最新[2023]版:
大类 | 4 区 医学
小类 | 4 区 泌尿学与肾脏学
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出版当年[2022]版:
Q1 UROLOGY & NEPHROLOGY
最新[2023]版:
Q1 UROLOGY & NEPHROLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2022版] 出版当年五年平均 出版前一年[2021版] 出版后一年[2023版]

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第一作者机构: [a]Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China [b]Key Laboratory ofNephrology, National Health Commission and Guangdong Province, Guangzhou, China
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通讯机构: [b]Key Laboratory ofNephrology, National Health Commission and Guangdong Province, Guangzhou, China [w]Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
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