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


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Department of Nephrology, State Key Laboratory of Kidney Disease, Chinese People's Liberation Army General Hospital, Beijing 100853, China.
Jian-Hui
JH
Zhou
Zhao-Hui
ZH
Ni
Chang-Lin
CL
Mei
Xue-Qing
XQ
Yu
Fu-You
FY
Liu
Li-Ning
LN
Miao
Zhi-Hong
ZH
Liu
Wei-Jie
WJ
Yuan
Ai-Ping
AP
Zhang
Hong-Li
HL
Lin
Meng-Hua
MH
Chen
Jiang-Hua
JH
Chen
Jin-Yuan
JY
Zhang
Ya-Ni
YN
He
Jian
J
Chen
Jiu-Yang
JY
Zhao
Xiao-Qiang
XQ
Ding
Ying
Y
Li
Rong-Shan
RS
Li
Ru-Juan
RJ
Xie
Wen-Hu
WH
Liu
Chang-Ying
CY
Xing
Rong
R
Wang
Yue-Yi
YY
Deng
Xue-Ying
XY
Cao
Guang-Yan
GY
Cai
Shan
S
Mou
Zhi-Guo
ZG
Mao
Xiao
X
Yang
Hong
H
Liu
Jing
J
Sun
Yu-Sheng
YS
Yu
Jun
J
Liu
Shu-Mei
SM
Shi
Long-Kai
LK
Li
Na
N
Tian
Xiao-Hui
XH
Zhang
Wei
W
Zhou
Jie
J
Yang
Yong
Y
Zhang
Jing-di
JD
Sun
Jun
J
Ji
Tao
T
Zhang
Yan
Y
Yan
Xiao-Gang
XG
Liu
Gang
G
Wang
Li
L
Zhang
Hong
H
Zhang
Jian-Hua
JH
Luo
Xiang-Mei
XM
Chen
D000293:Adolescent; D000328:Adult; D000368:Aged; D015314:Dialysis Solutions / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010530:Peritoneal Dialysis / Q000379:methods*; D055815:Young Adult
D015314:Dialysis Solutions