Effects of sulodexide in the prevention of peritoneal membrane changes in continuous ambulatory peritoneal dialysis patients

Abstract

The objective of this placebo-controlled clinical study is to determine the effect of sulodexide for the prevention of peritoneal membrane change in PD patients by evaluating dialysate biomarkers of peritoneal membrane change, phenotypes of peritoneal mesothelial cells, peritoneal membrane transports and safety. A total of 66 patients were included in this randomized control trial study. Patients were randomly assigned to receive either 50 mg of sulodexide or placebo by oral 2 times daily. PET was performed to evaluate peritoneal transport function. Dialysate CA125, IL-6 and VEGF concentration were also measured at baseline and after treatment by ELISA. Peritoneal mesothelial cell culture from dialysate effluent was done to evaluate EMT.

Overall, 61 patients completed the 3-month study. After the treatment period, there was a significantly lower D/P creatinine in the sulodexide group than in the placebo group (p-value = 0.04). However, no difference in D/D0 glucose was observed between two groups. For ultrafiltration volume, there was a significantly higher volume in the sulodexide group when compared to the placebo group (p-value = 0.01). Patients in the sulodexide group had no difference change from baseline in CA125 concentration while there was a significantly lower CA125 level in the placebo group (p-value = 0.03). However, no significant difference in CA125 was found between the two groups. For IL-6 , a significantly higher level was found within the placebo group after the treatment period (p-value < 0.01) while there was no difference change within the sulodexide group. When compared between groups, a significantly higher IL-6 level was found in the placebo group than those in the sulodexide group (p-value = 0.03). No difference was observed for VEGF changes both within and between two groups of patients. In conclusion from overall results in this study, the administration of sulodexide has a potentially beneficial effect in the prevention of peritoneal membrane damage in CAPD patients. Sulodexide may be used to slow the progression of peritoneal membrane change.