Effects of hydrophilic polymer-coated polysulfone membrane dialyzers on intradialytic hypotension in diabetic hemodialysis patients (ATHRITE BP Study) : a pilot study

Background: Intradialytic hypotension (IDH) is a common clinical manifestation associated with poor prognosis in hemodialysis (HD) patients. HD patients who suffer from diabetic nephropathy (DN) are increasing and diabetes is a major cause of IDH. Effective interventional treatments for IDH have yet to be fully evaluated. The aim of this multicenter prospective study is to clarify the effect of biocompatible hydrophilic polymer-coated polysulfone (PS) membrane, TORAYLIGHT® NV (NV) dialyzers on IDH. Methods: This is a prospective stratified-randomized multicenter trial. Forty DN patients undergoing HD and receiving two or more times of treatments for IDH per month were enrolled in this study. They were stratified by the number of treatments for IDH and divided to two groups using NV or conventional PS/polyethersulfone (PES) dialyzers. The number of treatments for IDH and changes in systolic blood pressure (SBP) were monitored for 6 months. Patients’ demographic and clinical characteristics were also collected at enrollment and the last month of the observation period. In order to clarify the patient characteristics that induced preferable effects by using NV dialyzers, responders were defined as the patients whose average SBP falls in 1 month improved from over 30 mmHg to no more than 30 mmHg. Results: The total number of treatments for IDH decreased significantly in NV group, even though pre-dialysis body weight and ultrafiltration volume were similar. In addition, patients using NV had significantly higher post-dialysis SBP and the lowest SBP during HD at sixth month compared as those in PS/PES group. NV responders had valuables suggesting malnutrition and microinflammation, and better lipid profiles than non-responders. However, the representative markers related to nutritional status, arteriosclerosis, and inflammation were not improved by NV treatment. Conclusions: NV had preferable effects on IDH in DN HD patients. Our results suggest the usefulness of NV as a possible method to deal with IDH. Further studies are needed to clarify the mechanism of NV effects on hemodynamic status

Comparison of Mortality between Japanese Peritoneal Dialysis and Hemodialysis Patients: A 5-Year Multicenter Follow-Up Study

To examine the relationship between dialysis modality and prognosis in Japanese patients, we conducted a prospective multicenter observational study. We recruited 83 background-matched peritoneal dialysis (PD) and 83 hemodialysis (HD) patients (average age, 64.9 years; men, 53.6%; diabetic patients, 22.9%; median duration of dialysis, 48 months in all patients) and followed them for 5 years. During the follow-up period, 27 PD patients (16 cardiovascular and 11 non-cardiovascular deaths) and 27 HD patients died (14 cardiovascular and 13 non-cardiovascular deaths). There were 8 PD patients switched to HD, and 6 PD patients received renal transplantation. Kaplan-Meier analysis revealed that the crude survival rate was not significantly different at the end of 5 years (PD 67.5% versus 67.5%, log-rank P = 0.719). The difference in cardiovascular and non-cardiovascular mortalities between PD and HD was not statistically significant. Multivariate Cox analysis showed that the independent predictors for death were age and serum albumin levels, but not the dialysis modality. This study showed that the overall mortality was not significantly different between PD and HD patients, which suggests that dialysis modality might not be an independent factor for survival in Japanese patients

Long-Term Safety and Efficacy of JR-131, a Biosimilar of Darbepoetin Alfa, in Japanese Patients With Renal Anemia Undergoing Hemodialysis: Phase 3 Prospective Study

The objective of this study was to evaluate the safety and efficacy of JR-131, a biosimilar of darbepoetin alfa, for long-term treatment of renal anemia patients undergoing hemodialysis. In this multicenter, single-arm, phase 3 study, 159 patients with renal anemia who had been receiving darbepoetin alfa or recombinant human erythropoietins were treated with intravenous JR-131 for 52 weeks. In patients receiving darbepoetin alfa, JR-131 was administered at the same dose, while in patients receiving recombinant human erythropoietin the dose was determined based on the 1:200 conversion ratio following the Japanese darbepoetin alfa package insert. No notable adverse drug reactions were reported, and no anti-JR-131 antibodies were detected. The hemoglobin levels were maintained in the range of 10.0-12.0 g/dL throughout the study. JR-131 proved to be a useful and lower-cost alternative to darbepoetin alfa in the management of renal anemia in patients undergoing hemodialysis