Efficacy and safety of Changfu peritoneal dialysis solution: a multi-center prospective randomized controlled trial

• Published in: Chinese medical journal Vol. 126; no. 22; pp. 4204 - 4209
• Main Authors: Zhou, Jian-Hui, Ni, Zhao-Hui, Mei, Chang-Lin, Yu, Xue-Qing, Liu, Fu-You, Miao, Li-Ning, Liu, Zhi-Hong, Yuan, Wei-Jie, Zhang, Ai-Ping, Lin, Hong-Li, Chen, Meng-Hua, Chen, Jiang-Hua, Zhang, Jin-Yuan, He, Ya-Ni, Chen, Jian, Zhao, Jiu-Yang, Ding, Xiao-Qiang, Li, Ying, Li, Rong-Shan, Xie, Ru-Juan, Liu, Wen-Hu, Xing, Chang-Ying, Wang, Rong, Deng, Yue-Yi, Cao, Xue-Ying, Cai, Guang-Yan, Mou, Shan, Mao, Zhi-Guo, Yang, Xiao, Liu, Hong, Sun, Jing, Yu, Yu-Sheng, Liu, Jun, Shi, Shu-Mei, Li, Long-Kai, Tian, Na, Zhang, Xiao-Hui, Zhou, Wei, Yang, Jie, Zhang, Yong, Sun, Jing-di, Ji, Jun, Zhang, Tao, Yan, Yan, Liu, Xiao-Gang, Wang, Gang, Zhang, Li, Zhang, Hong, Luo, Jian-Hua, Chen, Xiang-Mei
• Format: Journal Article
• Language: English
• Published: China Department of Nephrology, State Key Laboratory of Kidney Disease,Chinese People's Liberation Army General Hospital, Beijing 100853,China%Renal Division, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200127, China%Division of Nephrology, Kidney Institute of People's Liberation Army, Changzheng Hospital, Second Military Medical University,Shanghai 200003, China%Department of Nephrology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong 510080, China%Department of Nephropathy, Second Xiangya Hospital, Central South University, Changsha, Hunan 410011, China%Department of Nephropathy, the Second Hospital of Jilin University,Changchun, Jilin 130041, China%Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, Jiangsu 210002, China 20.11.2013
• Subjects: Adolescent; Adult; Aged; Dialysis Solutions - therapeutic use; Female; Humans; Male; Middle Aged; Peritoneal Dialysis - methods; Young Adult; safety; efficacy; Changfu peritoneal dialysis solution
• ISSN: 0366-6999; 2542-5641
• DOI: 10.3760/cma.j.issn.0366-6999.20131722

A multi-center large scale study is needed to confirm the efficacy and safety of domestic peritoneal dialysis (PD) solutions. Some researchers believe that 6 L/d is enough for adequate dialysis, but there is no multi-center prospective study on Chinese population to confirm this. In this study, we evaluated the efficacy and safety of domestic PD solution (Changfu) and its difference between 6 L and 8 L dosage. Adult PD patients who had taken PD therapy for at least one month were selected and divided into four groups according to two dialysis solution brands and two dialysis dosages, i.e., 6 L dose with Changfu dialysis solution, 6 L dose with Baxter dialysis solution, 8 L dose with Changfu dialysis solution, and 8 L dose with Baxter dialysis solution. After 48 weeks, the changes of primary and secondary efficacy indices were compared between different types and different dosages. We also analyzed the changes of safety indices. Changes of Kt/V from baseline to 48 weeks between Changfu and Baxter showed no statistical differences; so did those of creatinine clearance rate (Ccr). Normalized protein catabolic rate (nPCR) from baseline to 48 weeks between Changfu and Baxter showed no statistical differences; so did those of net ultrafiltration volume (nUF) and estimated glomerular filtration rate (eGFR). Changes of nPCR from baseline to 48 weeks between 6 L and 8 L showed no statistical differences; so did those of nUF and eGFR. The decline of Kt/V from baseline to 48 weeks in 6 L group was more than that in 8 L group. Change of Ccr was similar. During the 48-week period, the mean Kt/V was above 1.7/w, and mean Ccr was above 50 L×1.73 m(-2)×w(-1). More adverse events were found in Changfu group before Changfu Corporation commenced technology optimization, and the statistical differences disappeared after that. The domestic PD solution (Changfu) was proven to be as effective as Baxter dialysis solution. During 48-week period, a dosage of 6 L/d was enough for these patients to reach adequate PD. Clinical study promotes technological optimization, further helps to improve the safety indices of the medical products.