Currently Recruiting13 studies
−+Hemodialysis · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
This interventional study evaluates the impact of expanded hemodialysis (HDx) using the Theranova dialyzer on symptom burden and quality of life in patients with ESRD. Following a four-week baseline period, participants transition to the Theranova dialyzer for 24 weeks to assess if the clearance of larger middle molecules improves patient-reported outcomes. Investigators utilize the London Evaluation of Illness (LEVIL) application to collect real-time symptom data during one to three treatments per week. Secondary endpoints include changes in cognitive function via Creyos testing and assessments of sexual desire. The trial aims to determine if the biochemical advantages of HDx translate into immediate, measurable improvements in clinical symptomology.
Pre-dialysis CKD, Hemodialysis · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
This pilot exploratory study evaluates cardiac sodium deposition across the spectrum of renal impairment using sodium and proton MRI. Investigators compare approximately 150 participants, including hemodialysis patients, patients with various stages of CKD, and age-matched healthy controls. The study correlates cardiac sodium content with biomarkers of cardiac stress, fluid volume measured by bioimpedance spectroscopy, and MRI-derived measures of cardiac function and fibrosis. The primary objective is to determine if myocardial sodium retention relates to cardiac structural abnormalities and to establish a baseline for future interventional studies.
Hemodialysis · CSL Behring
This phase 2b/3 multicenter, randomized, double-blind trial evaluates the efficacy and safety of clazakizumab (CSL300), a monoclonal antibody targeting IL-6, in patients with ESKD undergoing maintenance dialysis. The study population includes patients with systemic inflammation who have either established ASCVD or diabetes. Part 1 functions as a dose-finding phase, while Part 2 assesses the impact of clazakizumab on major cardiovascular outcomes compared to placebo. The primary objective is to determine if IL-6 inhibition reduces cardiovascular events in this high-risk population.
Hemodialysis · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
DIALEX is a pragmatic, open-label, randomized superiority trial evaluating the clinical efficacy of expanded hemodialysis compared to conventional high-flux hemodialysis in patients with ESKD. The study enrolls 4,800 participants across community and academic facilities to determine if the use of super high-flux dialyzers, which enhance the removal of large middle molecules, reduces all-cause mortality. Participants are randomized to receive either expanded hemodialysis using Nipro Elisio HX dialyzers or standard care with conventional high-flux filters during their regularly scheduled treatments. Researchers utilize administrative healthcare databases and medical record reviews to track longitudinal outcomes over a mean follow-up period of 2.9 years. The trial is powered to detect a 15% relative reduction in the hazard of death.
Hemodialysis · McMaster University
This pragmatic, open-label, randomized superiority trial compares the clinical outcomes of two standard dialysate bicarbonate concentrations in patients receiving maintenance hemodialysis. Participants are randomized 1:1 to receive a dialysate bicarbonate concentration of either 32 mmol/L or 38 mmol/L, with the intervention embedded into routine care. The study evaluates whether a lower versus higher concentration reduces the risk of the primary outcomes: all-cause mortality and recurrent non-elective hospitalizations. Secondary endpoints include cardiovascular-related hospitalizations, infection-related hospitalizations, and fractures. Data collection utilizes provincial administrative databases to track long-term outcomes within this Ontario-based population.
Prospective cohort to evaluate the dialytic clearance of tranexamic acid.
Hemodialysis · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
This randomized crossover-controlled trial evaluates the cardioprotective effects of exercise preconditioning in patients undergoing maintenance hemodialysis. Investigators compare intradialytic cycling performed immediately prior to treatment against standard care to determine if pre-dialysis exertion mitigates dialysis-induced myocardial stunning. The primary objective is to assess changes in regional wall motion abnormalities and left ventricular ejection fraction during the dialysis session. Secondary endpoints include the frequency and severity of intradialytic symptoms and overall hemodynamic stability. The study aims to establish whether exercise preconditioning serves as a viable therapeutic strategy to reduce long-term heart failure risk in this population.
Hemodialysis · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
This observational study investigates the temporal patterns of interdialytic weight gain and blood pressure fluctuations in approximately 20 patients receiving thrice-weekly HD. The study excludes patients with diabetes or significant residual urine volume to minimize osmotic and renal confounders of thirst. Participants perform prospective home monitoring of body weight and blood pressure four times daily for one week while completing validated assessments for xerostomia, thirst perception, and dietary sodium intake. The primary objective is to characterize the relationship between fluid intake timing and the post-dialysis interval to better understand the drivers of ultrafiltration requirements.
Hemodialysis, Peritoneal dialysis, Pre-dialysis CKD · Western University, Canada
OK-TRANSPLANT 2 is a pragmatic, open-label vanguard study evaluating the feasibility of a weight loss intervention for patients with obesity and high-risk CKD or ESKD seeking kidney transplantation. Participants are randomized to receive either a virtual weight management program, which includes semaglutide and coaching, or standard of care. The study assesses recruitment feasibility, treatment adherence over 26 weeks, and the safety profile of GLP-1RA therapy in this specific population. The primary objective is to determine the viability of a larger multicenter trial aimed at reducing BMI-related barriers to transplant waitlisting.
Hemodialysis · The University of Queensland
This pragmatic, international, randomized trial evaluates whether intensive serum phosphate lowering improves cardiovascular outcomes in 3,600 adult patients with ESKD receiving dialysis. Participants are randomized to either an intensive phosphate target (≤1.50 mmol/L) or a liberal target (2.0–2.5 mmol/L) using physician-discretionary phosphate binders. The primary endpoint is a composite of cardiovascular death and non-fatal major cardiovascular or peripheral arterial events. Secondary outcomes include all-cause mortality, health-related quality of life, and cost-effectiveness. The study aims to provide high-level evidence for current clinical guidelines that suggest targeting normal phosphate levels despite a lack of definitive prospective data.
Hemodialysis · University of Sydney
The RESOLVE trial is a pragmatic, cluster-randomized, open-label study evaluating the comparative effectiveness of two default dialysate sodium concentrations in patients with ESKD receiving maintenance hemodialysis. Dialysis centers are randomized 1:1 to a default dialysate sodium of either 137 mmol/L or 140 mmol/L, with the default concentration applied to at least 90% of sessions at each site. The primary objective is to assess the impact of these concentrations on major cardiovascular events and all-cause mortality under real-world clinical conditions. All other aspects of care follow standard local practices, and outcomes are analyzed at the individual patient level.
Hemodialysis · Chris McIntyre
This pilot study evaluates non-osmotic sodium deposition in the skin, muscle, and skeleton of patients with CKD stages 1-5, maintenance hemodialysis, peritoneal dialysis, and heart failure. Investigators utilize novel Na+ MRI of the lower leg to quantify tissue sodium content and compare findings against age- and sex-matched healthy controls. The study examines the association between these sodium stores, uremic symptomatology, and biochemical markers of metabolism and inflammation. Clinical assessments include symptom questionnaires, functional physical testing, echocardiography, and laboratory analysis of blood and urine. Participants undergo an initial assessment with potential follow-up visits over a two-year period to track changes in sodium deposition and clinical status.
Hemodialysis · London Health Sciences Centre Research Institute
This Phase 2 exploratory study evaluates the neuroprotective effects of AV-001 in patients undergoing maintenance hemodialysis. Investigators aim to determine if AV-001 stabilizes the cerebrovascular endothelium and reduces inflammation to mitigate hemodialysis-induced brain injury. Participants are randomized to receive either a low dose of AV-001, a high dose of AV-001, or a placebo administered 60 minutes prior to three consecutive hemodialysis sessions. Clinical outcomes are assessed through serial cognitive testing, vascular ultrasound, and MRI to monitor structural and functional neurological changes.
