ABSTRACT
Background: Dialysis patients have been maintaining a high rate of cardiovascular morbidity and mortality. For this reason, it is to introduce necessary new technical advances in clinical practice. There is a relation between toxins retention and inflammation, mortality and morbidity. Medium cut-off (MCO) membranes are a new generation of membranes that allow the removal of a greater number of medium-sized molecules compared with high-flux hemodialysis (HF-HD), but retaining albumin. MCO membranes have an increased permeability and the presence of internal filtration. Because of these special properties, MCO generated a new concept of therapy called expanded HD (HDx). Until now, online hemodiafiltration (OL-HDF) has demonstrated its superiority, in terms of survival, compared with HF-HD. However, the comparison between OL-HDF and HDx remains an unsolved question. Methods: The MOTheR HDx study trial (NCT03714386) is an open-label, multicenter, prospective, 1:1 randomized, parallel-group trial designed to evaluate the efficacy and safety of HDx compared with OL-HDF in patients treated for dialysis in Spain for up to 36 months. The main endpoint is to determinate whether HDx is non inferior to OL-HDF at reducing the combined outcome of all-cause death and stroke (ischemic or hemorrhagic), acute coronary syndrome (angina and myocardial infarction), peripheral arterial disease (amputation or revascularization) and ischemic colitis (mesenteric thrombosis). Results: The trial has already started.
ABSTRACT
BACKGROUND: Chronic kidney disease (CKD) patients are at high-risk for severe coronavirus disease 2019 (COVID-19). The multicentric, observational and prospective SENCOVAC study aims to describe the humoral response and safety of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in CKD patients. Safety and immediate humoral response results are reported here. METHODS: Four cohorts of patients were included: kidney transplant (KT) recipients, and haemodialysis (HD), peritoneal dialysis (PD) and non-dialysis CKD patients from 50 Spanish centres. Adverse events after vaccine doses were recorded. At baseline and on Day 28 after the last vaccine dose, anti-Spike antibodies were measured and compared between cohorts. Factors associated with development of anti-Spike antibodies were analysed. RESULTS: A total of 1746 participants were recruited: 1116 HD, 171 PD, 176 non-dialysis CKD patients and 283 KT recipients. Most patients (98%) received mRNA vaccines. At least one vaccine reaction developed after the first dose in 763 (53.5%) and after the second dose in 741 (54.5%) of patients. Anti-Spike antibodies were measured in the first 301 patients. At 28 days, 95% of patients had developed antibodies: 79% of KT, 98% of HD, 99% of PD and 100% of non-dialysis CKD patients (P < 0.001). In a multivariate adjusted analysis, absence of an antibody response was independently associated with KT (odds ratio 20.56, P = 0.001) and with BNT162b2 vaccine (odds ratio 6.03, P = 0.023). CONCLUSION: The rate of anti-Spike antibody development after vaccination in KT patients was low but in other CKD patients it approached 100%, suggesting that KT patients require persistent isolation measures and booster doses of a COVID-19 vaccine. Potential differences between COVID-19 vaccines should be explored in prospective controlled studies.
