Efficacy and Safety of Sevelamer Carbonate in Chinese Nondialysis Chronic Kidney Disease Patients with Hyperphosphatemia: A Randomized, Double-Blind, Parallel-Group Study
| Autor: | Wei Chen, Hua-Feng Liu, Qin-Kai Chen, Ming-Hui Zhao, Xiao-Nong Chen, Hong Liu, Jian-Xin Wan, Shao-Mei Li, Meng-Hua Chen, Chun Dai, Hong-Bin Shi, Jia-Li Wei, Hong-Wen Zhao, Li-Hua Wang, Gang Long, Wan-Hong Lu, Ying Tang, Jun-Wei Yang, Li-Ying Cao, Dong-Xing Tang, Yu-Qiong Yang, Xue-Qing Yu |
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| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: | |
| Zdroj: | Kidney Diseases (2022) |
| Druh dokumentu: | article |
| ISSN: | 2296-9381 2296-9357 |
| DOI: | 10.1159/000527833 |
| Popis: | 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 |
| Databáze: | Directory of Open Access Journals |
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