Active Studies

Susan Huang· Victoria Hospital

Patients can be seen at: Victoria Hospital

This multicenter, multinational observational registry studies patients with atypical hemolytic-uremic syndrome (aHUS). It collects post-marketing safety data from patients treated with eculizumab or ravulizumab and from untreated patients; treatment is not assigned by the study. The registry also tracks disease progression in all enrolled patients.

Andrew House· University Hospital

This Phase 2, randomized, double-blind, placebo-controlled study evaluates the safety, tolerability, and efficacy of oral AV078 in participants with TSC-associated refractory epilepsy. Approximately 42 participants receive once-daily AV078 or matching placebo in a 5:1 ratio, in addition to a stable antiseizure medication regimen, for 12 weeks. AV078 is a selective mTORC1 inhibitor, and efficacy is assessed primarily by change in seizure frequency.

Pavel Roshanov· University HospitalLouise Moist· Victoria Hospitalstarting soon

Patients can be seen at: Victoria Hospital, University Hospital

GUARD-1 is a pilot randomized trial assessing the safety, tolerability, and feasibility of semaglutide use in adults with type 2 diabetes receiving maintenance dialysis for at least 90 days. Participants are randomized 1:1 to weekly subcutaneous semaglutide or usual care and followed for 26 weeks. The study evaluates recruitment, treatment adherence, and follow-up completeness to inform the feasibility of a larger cardiovascular outcomes trial, while also collecting safety and clinical outcomes.

Pavel Roshanov· University HospitalArsh Jain· Victoria Hospital

Patients can be seen at: University Hospital, Kidney Care Centre - Clinics, Victoria Hospital

This Phase III study evaluates whether elecoglipron (oral GLP-1RA) reduces renal outcomes and mortality compared with placebo in participants with CKD, with or without T2DM. Participants receive elecoglipron or placebo in a randomized, double-blind, parallel-group design. Treatment is added to background dapagliflozin and other standard-of-care CKD therapies.

Pavel Roshanov· University Hospital

This Phase III, randomised, double-blind, active-controlled study evaluates balcinrenone/dapagliflozin versus dapagliflozin, both added to standard-of-care therapy, in adults with stage 3b or 4 CKD (eGFR ≥15 to <45 mL/min/1.73 m²). Participants receive once-daily balcinrenone/dapagliflozin 15/10 mg or dapagliflozin 10 mg, with matching placebos. The study assesses renal and cardiovascular outcomes, including kidney failure, sustained ≥50% eGFR decline, CV death and HF events, as well as safety and tolerability.

This prospective observational study evaluates the role of the gut microbiome in modulating response to semaglutide in participants with diabetes and obesity. The primary objective is to determine whether baseline and longitudinal differences in gut microbial composition are associated with variability in treatment effectiveness and gastrointestinal tolerability among individuals receiving GLP-1 receptor agonist therapy. Participants will be followed over 12 months with study assessments at baseline, 3, 6, and 12 months. Data collection includes stool samples, bloodwork, body measurements, and validated questionnaires assessing diet, physical activity, medication adherence, and gastrointestinal symptoms. Clinical data will be obtained from medical records where available to support evaluation of metabolic outcomes and treatment-related adverse effects.

This qualitative study evaluates experiences of heart and kidney care among women with diabetes. The primary objective is to identify barriers, supports, and care needs related to cardiovascular and kidney health, and to better understand how healthcare delivery can be optimized for this population. Participants will complete a one-time semi-structured interview with a trained member of the research team. Interviews may be conducted in person, by phone, or virtually and will explore experiences with diabetes care, management of heart and kidney health, and perspectives on improving care delivery. Interviews will be recorded and transcribed for analysis, and clinical context may be collected where relevant to support interpretation of findings.

This prospective, single-arm study evaluates the impact of GLP-1RA or GLP-1RA/GIP agonists on muscle and bone health in 20 patients with type 2 diabetes. Investigators utilize advanced PET/CT imaging at baseline, 3, 6, and 12 months to quantify changes in intramuscular fat, bone blood flow, and glucose metabolism following medication initiation. The study also tracks longitudinal changes in physical function through grip strength, gait speed, and Timed Up and Go assessments. The primary objective is to characterize early markers of sarcopenia and bone fragility to assist in the development of clinical prediction tools for patients at high risk of frailty. Findings aim to guide the integration of bone-protecting therapies or physical therapy for patients prescribed semaglutide or tirzepatide.

Arsh Jain· Victoria Hospital

High blood pressure affects 45% of adults worldwide and is the biggest risk factor for cardiovascular disease. Despite there being many medications to treat high blood pressure approximately half of these patients had not achieved guideline recommended blood pressure goals. Clinical data from phase 1 and 2 studies have proven that a new medication Zilebesiran has the potential of lowering blood pressure with less frequent administration. (Every 6 months) Reducing blood pressure significantly reduces cardiovascular risks. The goal of this study is to evaluate if Zilebesiran verses Placebo reduces the risk of cardiovascular death, nonfatal heart attacks, strokes or heart failure events.

Arsh Jain· Victoria Hospital

This multicenter, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of BI 764198, an oral TRPC6 inhibitor, in adults and adolescents with primary FSGS or genetic FSGS related to TRPC6 variants. Participants are randomized to receive either BI 764198 or placebo once daily for 104 weeks as an adjunct to standard of care. The study assesses the drug's impact on disease progression and kidney function through regular monitoring of UPCR and adverse events. The primary objective is to determine if TRPC6 inhibition reduces proteinuria and stabilizes renal function over a long-term treatment period.

Susan Huang· Victoria Hospital

This Phase 2 study evaluates the safety, tolerability, and efficacy of atacicept in adult and adolescent patients aged 10 and older with autoimmune glomerular diseases. The target population includes patients diagnosed with IgAN, pMN, MCD, or FSGS. Participants receive weekly subcutaneous injections of atacicept to determine its impact on reducing UPCR and preserving renal function. Primary endpoints focus on the drug's safety profile and its ability to achieve clinical remission across these specific nephropathies.

Susan Huang· Victoria Hospital

This Phase 3, open-label, randomized trial evaluates the efficacy and safety of felzartamab compared to tacrolimus in patients with primary membranous nephropathy (PMN). The study population consists of adults with PMN at risk of progressive kidney disease, characterized by persistent proteinuria and the presence of autoantibodies. The primary endpoint is the proportion of participants achieving a complete response, defined by a significant reduction in UPCR and stable eGFR, at 104 weeks. Secondary objectives include assessing the time to disease progression, duration of remission, safety profiles, and the impact of felzartamab on anti-PLA2R antibody titers. Participants receive either intravenous felzartamab or oral tacrolimus, with provisions for rescue therapy in cases of treatment failure or disease relapse.

Christopher McIntyre· Victoria Hospital

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.

Matthew Weir· University Hospital

This Phase 3, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of mezagitamab in adults with primary IgAN receiving stable background therapy. The study assesses the impact of mezagitamab on proteinuria reduction, measured by UPCR, and its ability to maintain kidney function over time. Participants are randomized 2:1 to receive either mezagitamab or placebo in two 1-year cycles, with an additional open-label cohort for patients with lower eGFR or prior mezagitamab exposure. Secondary endpoints include safety, tolerability, and long-term changes in eGFR to determine the drug's potential in mitigating immune complex-mediated kidney damage.

Matthew Weir· University Hospital

This Phase III multicenter, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of iptacopan, an oral proximal complement inhibitor, in adults and adolescents with idiopathic IC-MPGN. Participants receive either iptacopan or placebo in addition to standard of care to assess the drug's impact on alternative complement pathway dysregulation. The primary objectives are to demonstrate a reduction in proteinuria, measured by UPCR, and stabilization or improvement in eGFR. Secondary endpoints include changes in patient-reported fatigue and long-term safety profiles. Following the double-blind period, eligible participants may transition to an open-label extension study.

Dervla Connaughton· University Hospital

This multi-center study evaluates the clinical and economic impact of genetic testing in patients with CKD who meet Ontario Health's Provincial Genetic Program criteria for suspected genetic kidney disease. Participants receive either genome-wide sequencing or standard genetic testing based on the timing of their initial diagnosis. The study assesses patient and caregiver quality of life, healthcare resource utilization via ICES data linkage, and the perceived clinical utility of testing as reported by referring physicians. Researchers also perform an economic analysis to compare genome-wide sequencing against standard testing protocols to determine the optimal timing and method for genomic assessment in CKD management.

This phase III, randomized, double-blind, sham-controlled trial evaluates the efficacy of continuous transversus abdominis plane (TAP) catheter infusions for postoperative pain management in kidney transplant recipients. Investigators randomize patients to receive either a continuous infusion of ropivacaine or a saline sham via a surgically placed TAP catheter for 48 hours. Both cohorts receive a standardized multimodal analgesic regimen consisting of a PCA pump, acetaminophen, and gabapentin. The study aims to determine if regional local anesthetic delivery reduces opioid consumption and improves pain control compared to standard systemic analgesia alone in this surgical population.

This single-blind randomized controlled trial evaluates the efficacy of sodium thiosulfate (STS) as an additive to cold organ preservation solutions for patients undergoing kidney transplantation. Investigators aim to mitigate ischemia-reperfusion injury and delayed graft function by utilizing STS as a clinically viable hydrogen sulfide donor during the ex vivo pumping process. The study population consists of transplant recipients receiving kidneys from deceased donors, a group at high risk for reduced graft viability due to prolonged cold storage and metabolic demand. Following the intervention, participants are monitored for one year via serial blood and urine collections to assess graft function and long-term clinical outcomes.

Louise Moist· Victoria Hospital

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.

Andrew House· University Hospital

The purpose of this study is the evaluate the clinical characteristics of adults with tuberous sclerosis complex and to provide multidisciplinary care.

Amit Garg· Victoria Hospital

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.

Amit Garg· Victoria Hospital

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.

Dervla Connaughton· University Hospital

The purpose of the study is to identify underlying genetic causes of kidney disease using advanced genetic analysis techniques such as whole exome and genome sequencing.

Christopher McIntyre· Victoria Hospital

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.

Christopher McIntyre· Victoria Hospital

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.

Christopher McIntyre· Victoria Hospital

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.

Christopher McIntyre· Victoria Hospital

This prospective pilot study evaluates the utility of 23Na MRI in measuring kidney medullary sodium content to predict diuretic resistance in patients with chronic cardio-renal syndrome. Investigators compare baseline kidney sodium concentrations between patients with and without diuretic resistance and assess changes in sodium content following an intravenous dose of furosemide in the resistant cohort. Secondary measures include bioimpedance spectroscopy, NYHA classification, echocardiographic parameters, and 24-hour urine volume. The study aims to determine if 23Na MRI can quantify the intrarenal response to loop diuretics and guide precision dosing to overcome treatment failure.

Christopher McIntyre· Victoria Hospital

This pilot exploratory study evaluates the use of 23Na MRI to quantify the renal corticomedullary sodium gradient in approximately 200 patients with CKD, nephrolithiasis, or ADPKD. Investigators utilize sodium-specific functional imaging to non-invasively measure medullary sodium concentration, a key determinant of urinary concentrating capacity. Clinical assessments include standardized blood pressure monitoring, serum labs, and spot UPCR/UACR, with 24-hour urine collections required for the nephrolithiasis cohort. The study aims to determine if alterations in the sodium gradient correlate with disease progression and to validate 23Na MRI as a functional biomarker for renal medullary health.

Christopher McIntyre· Victoria Hospital

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.

Christopher McIntyre· Victoria Hospital

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.

Arsh Jain· Victoria Hospital

Patients can be seen at: Kidney Care Centre - Dialysis

This pragmatic, multicenter randomized controlled trial evaluates the efficacy of the VIEWER virtual care platform in patients with advanced CKD (Stage 5) or ESRD. The intervention integrates a mobile tablet application with wireless devices to monitor BP, weight, oxygen saturation, and step counts, alongside weekly ESAS-r symptom surveys. These data are transmitted to a provider portal where clinicians receive flags for out-of-range values to inform multidisciplinary care and volume management. The study's primary objective is to determine if this semi-continuous telemonitoring reduces the composite of ED visits and hospitalizations compared to usual care during the high-risk transition toward dialysis. Secondary outcomes include all-cause mortality, acute inpatient dialysis initiation, and patient-reported quality of life assessed by KDQOL-SF and PREM scores.

Matthew Weir· University Hospital

This Phase 2a, multicenter, randomized, double-blind, placebo-controlled umbrella study evaluates the efficacy and safety of three investigational agents—frexalimab, brivekimig, and rilzabrutinib—in patients aged 16 to 75 with primary FSGS or MCD. The primary objective is to assess changes in proteinuria and nephrotic syndrome remission rates over a 24-week treatment period. Participants are randomized across six treatment arms to compare these novel therapies against placebo. Key clinical outcomes focus on reductions in UPCR and the achievement of complete or partial clinical remission. The total study duration lasts up to 76 weeks, including a long-term follow-up phase to monitor safety and durability of response.

Matthew Weir· University Hospital

Patients can be seen at: University Hospital

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.

Matthew Weir· University Hospital

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.

Matthew Weir· University Hospital

Patients can be seen at: University Hospital, Kidney Care Centre - Clinics

This Phase III, randomized, double-blind, event-driven trial evaluates the efficacy and safety of baxdrostat in combination with dapagliflozin versus dapagliflozin alone in patients with CKD and hypertension. The primary objective is to determine if adding this aldosterone synthase inhibitor to SGLT2i therapy reduces the risk of a composite endpoint including a ≥50% sustained decline in eGFR, kidney failure, or CV death. Participants not previously on an SGLT2i undergo a 4-week dapagliflozin run-in period prior to randomization. The study monitors long-term renal and cardiovascular outcomes through regular clinical assessments until a predetermined number of primary events occur.

Pavel Roshanov· University Hospital

This Phase 1a/1b randomized, double-blind, placebo-controlled trial evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of GSK4771261. Part A assesses single ascending doses in healthy participants to determine the drug's safety profile and systemic impact. Part B investigates the intervention in patients with autosomal dominant polycystic kidney disease (ADPKD) to establish initial clinical data in the target population. The study monitors standard safety parameters and physiological responses to inform future dosing strategies for chronic kidney disease management.

Pavel Roshanov· University Hospital

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.

Pavel Roshanov· University Hospital

The BRACKETS pilot trial is a multicentre, randomized controlled trial evaluating the feasibility and safety of prophylactic preoperative tranexamic acid (TXA) and desmopressin in patients with advanced CKD or AKI undergoing noncardiac surgery. Utilizing a partial factorial design, the study compares TXA versus placebo and desmopressin versus placebo to address the increased bleeding risk associated with impaired primary hemostasis in this population. The trial aims to provide preliminary efficacy data and pharmacokinetic profiles to inform dose selection for a larger international phase. Investigators seek to determine if these generic agents reduce perioperative bleeding complications in a high-risk cohort typically excluded from major surgical trials.

Matthew Weir· University Hospitalstarting soon

Patients can be seen at: University Hospital, Kidney Care Centre - Dialysis

SAFE-D2 evaluates whether apixaban reduces ischemic stroke or systemic embolism compared with no oral anticoagulation in adults receiving maintenance hemodialysis or peritoneal dialysis who have nonvalvular AF and elevated stroke risk. Participants are randomized to apixaban or no oral anticoagulant while continuing usual dialysis and medical care. The trial also assesses mortality, cardiovascular events, bleeding, hospitalizations, dialysis access thrombosis, and health-related quality of life.

Susan Huang· Victoria Hospitalstarting soon

The purpose of this study is to determine if BHV-1400 is effective and safe in the treatment of IgA Nephropathy. Participants will be randomized in a 2:1 ratio to receive either BHV-1400 or placebo.

Louise Moist· Victoria Hospitalstarting soon

The GiFT study is a prospective, multicentre observational cohort study of adults aged 18 to 80 years who recently started hemodialysis or peritoneal dialysis in Canada. Participants undergo objective and subjective frailty assessments within three months of dialysis initiation, including the Fried Frailty Phenotype, Frailty Index, Five Times Sit-to-Stand test, Clinical Frailty Scale, and Pictorial Fit-Frail Scale. The primary objective is to determine whether frailty is associated with reduced or delayed kidney transplant referral and whether this relationship differs by gender. Secondary outcomes include time to transplant work-up completion, waitlist activation, and living donor contact.

Lakshman Gunaratnam· University Hospitalstarting soon

This single-center pilot study evaluates the safety and efficacy of alefacept in de novo kidney transplant recipients. The intervention combines alemtuzumab induction with alefacept, mycophenolic acid, and rapid withdrawal of both corticosteroids and calcineurin inhibitors. Alefacept is administered intravenously for two doses, followed by weekly subcutaneous injections through week 12 and monthly injections thereafter. Primary endpoints include the incidence of biopsy-proven acute rejection, infectious complications, and serious adverse events. Secondary outcomes focus on immune monitoring, specifically T-helper differentiation, cytokine production, and T-regulatory cell generation.

Christopher McIntyre· Victoria Hospitalstarting soon

This feasibility pilot study evaluates the safety and usability of a novel wearable Residual Ultrafiltration Device (RUF-D) in hemodialysis patients struggling with inadequate volume management. The intervention provides supplemental, slow fluid removal between standard hemodialysis sessions to mitigate the need for high ultrafiltration rates and reduce the risk of intradialytic hypotension and multi-organ ischemic injury. Investigators are enrolling 18 patients in a prospective, unblinded trial to compare volume status and clinical endpoints against baseline assessments. The primary objective is to determine if this simplified, wearable system can effectively offload fluid in patients who cannot tolerate conventional fluid removal within standard treatment time constraints.

Louise Moist· Victoria Hospital

This multicenter, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of the aldosterone synthase inhibitor BI 690517 in combination with empagliflozin in adults with CKD at risk of progression. Participants, with or without type 2 diabetes, are stabilized on an ACEi or ARB and empagliflozin before randomization to either BI 690517 or placebo. The primary objective is to assess the time to first occurrence of a composite clinical endpoint including worsening kidney disease, heart failure hospitalization, or cardiovascular death. Investigators monitor longitudinal changes in eGFR, UACR, and blood pressure over a follow-up period of approximately 3 to 4 years.

Susan Huang· Victoria Hospital

This Phase 3, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of ravulizumab in approximately 510 adults with IgAN at high risk of disease progression. Participants must be on a stable standard of care regimen for at least three months prior to screening and are randomized 1:1 to receive weight-based IV infusions of ravulizumab or placebo. The primary endpoints are the reduction in proteinuria at Week 34 and the change in eGFR at Week 106. The study includes a specific cohort for patients with advanced kidney disease (eGFR 20–29 mL/min/1.73m²) to assess outcomes in late-stage progression.

Susan Huang· Victoria Hospital

This Phase III, multicenter, randomized, double-blind trial evaluates the efficacy and safety of sefaxersen (RO7434656) in patients with primary IgA nephropathy at high risk of disease progression. The study population includes participants who demonstrate persistent risk despite receiving optimized supportive care. Sefaxersen is a novel antisense oligonucleotide designed to inhibit the production of complement factor B, targeting the alternative complement pathway. Investigators assess the drug’s impact on proteinuria, typically measured by UPCR or UACR, and its effect on stabilizing eGFR over time. The trial aims to determine if this targeted molecular approach reduces the risk of progressive kidney function decline compared to placebo.

Christopher McIntyre· Victoria Hospital

This study evaluates cerebrovascular reactivity (CVR) in patients with chronic kidney failure receiving hemodialysis to identify therapeutic targets for mitigating dialysis-related cognitive decline. Investigators use the RespirAct system to deliver controlled CO2 stimuli and Transcranial Doppler to measure middle cerebral artery blood flow velocity before and after hemodialysis sessions. The protocol correlates changes in CVR and cognitive performance—assessed via MoCA, Trails Making Tests, and computerized batteries—with hemodynamic variables and serum markers including sodium, calcium, and acid-base status. The primary objective is to determine how the hemodialysis procedure acutely impacts cerebral autoregulation and to establish parameters that may be modified to preserve brain vascular health in this population.

Christopher McIntyre· Victoria Hospital

The TICKERS-HD trial evaluates the impact of a 12-week intradialytic cycling program on myocardial stunning in adults with end-stage kidney disease receiving chronic hemodialysis. Investigators utilize echocardiography to assess changes in regional wall motion abnormalities and hemodialysis-related symptoms during aerobic exercise. The study aims to determine if regular intradialytic exercise mitigates recurrent ischemic cardiac injury and improves functional status in this high-risk population. This intervention targets the reduction of cardiac failure and mortality associated with treatment-induced myocardial stunning.

Arsh Jain· Victoria Hospital

This Phase 3, randomized, double-blind, event-driven trial evaluates the efficacy of retatrutide in reducing major adverse cardiovascular events (MACE) and major adverse kidney events (MAKE). The study enrolls adults with a BMI ≥27 kg/m² who have established ASCVD, CKD, or both. Participants receive either subcutaneous retatrutide or placebo for approximately five years to assess long-term clinical outcomes. Primary endpoints focus on the incidence of serious cardiovascular complications and the progression of renal dysfunction. Secondary outcomes include changes in weight, eGFR, and UACR over the study period.

Pavel Roshanov· University Hospital

This Phase III, randomized, double-blind, active-controlled trial evaluates the efficacy of balcinrenone/dapagliflozin compared to dapagliflozin monotherapy in patients with chronic heart failure and impaired kidney function (eGFR 20-60) who are not taking an MRA (spironolactone, eplerenone, finerenone). Participants are randomized 1:1:1 to receive either 15 mg/10 mg balcinrenone/dapagliflozin, 40 mg/10 mg balcinrenone/dapagliflozin, or 10 mg dapagliflozin once daily. The primary objective is to assess the impact of these interventions on the risk of cardiovascular death and heart failure events, including those with and without hospitalization. This event-driven study monitors outcomes over an estimated 20-month blinded treatment period.

Matthew Weir· University Hospital

This Phase III, randomized, double-blind trial evaluates the efficacy and safety of baxdrostat, a selective aldosterone synthase inhibitor, in combination with dapagliflozin for patients with CKD and hypertension. The study population includes adults with CKD and high blood pressure who are either SGLT2i-naive or currently receiving SGLT2i therapy. Participants receive a 4-week dapagliflozin run-in period if treatment-naive, followed by a 24-month double-blind phase comparing baxdrostat/dapagliflozin to dapagliflozin plus placebo. The primary efficacy endpoint assesses CKD progression via changes in GFR following a 6-week open-label dapagliflozin washout period. Secondary outcomes focus on the long-term safety and tolerability of the combination regimen in this high-risk population.

Amit Garg· Victoria Hospital

This pragmatic, cluster-randomized trial evaluates the clinical impact of dialysate magnesium concentrations in outpatients receiving maintenance hemodialysis. Participating centers are randomized to a higher dialysate magnesium concentration of 1.5 mEq/L (0.75 mmol/L) or a lower concentration of ≤1.0 mEq/L (≤0.5 mmol/L). The study aims to determine if increasing dialysate magnesium reduces the risk of all-cause mortality and cardiovascular-related hospitalizations. Secondary outcomes include the frequency of intradialytic muscle cramps and other patient-reported measures. The trial utilizes routinely collected healthcare data to assess outcomes across a broad, representative population of patients with end-stage kidney disease.

Susan Huang· Victoria Hospitalstarting soon

This Phase 3b, open-label continuation study evaluates the long-term safety and efficacy of TAK-755 (rADAMTS13) in patients with severe congenital thrombotic thrombocytopenic purpura (cTTP). The study enrolls both treatment-naïve patients and those transitioning from previous TAK-755 trials to receive either prophylactic or on-demand enzyme replacement therapy. Participants in the prophylactic cohort receive weekly or biweekly intravenous infusions to prevent acute TTP events, while the on-demand cohort receives daily dosing for the management of acute flares. The primary objective is to characterize the long-term safety profile and the ability of rADAMTS13 to maintain ADAMTS13 activity levels and prevent thrombotic microangiopathy. Treatment duration extends up to three years, with options for home-based self-infusion or caregiver administration in the prophylactic arm.

This randomized, double-blind, pilot study evaluates the safety and efficacy of human milk oligosaccharides (HMO) in approximately 60 patients undergoing kidney transplantation. Participants receive either HMO prebiotic sachets or placebo for 12 weeks to determine if prebiotic therapy reduces delayed graft function and mitigates gastrointestinal side effects associated with post-transplant immunosuppression. The study monitors graft function through serial blood and urine samples, while microbiome changes are assessed via fecal analysis at six time points. Researchers utilize SF-36 and GI health questionnaires to measure quality of life and treatment tolerability over a six-month follow-up period. The primary objective is to determine if HMO-driven production of short-chain fatty acids improves the gut-kidney axis and stabilizes systemic inflammatory responses in this population.

This phase 2b, non-randomized, open-label extension study evaluates the long-term persistence of immune response and the safety of revaccination with the adjuvanted RSVPreF3 vaccine. The target population includes adults ≥18 years of age who have undergone lung or kidney transplantation and are receiving chronic immunosuppressive therapy. Participants previously received either one or two doses of the vaccine in a parent study and now receive an additional dose to assess immunogenicity and safety profiles. Investigators analyze immune persistence separately based on prior dosing schedules while aggregating safety and demographic data across the revaccination cohort.

Matthew Weir· University Hospital

The BEYOND study evaluates the safety and efficacy of BION-1301, a humanized monoclonal antibody, in adults with biopsy-proven IgA nephropathy. Participants are randomized to receive 600 mg of BION-1301 or placebo via subcutaneous injection every two weeks for 104 weeks. The primary analysis population includes patients with an eGFR ≥ 30 mL/min/1.73m², while an exploratory cohort assesses patients with an eGFR between 20 and 30 mL/min/1.73m². The primary objective is to determine the impact of BION-1301 on proteinuria reduction compared to placebo. Secondary outcomes include long-term safety and the preservation of renal function over a 2.5-year study period.

Matthew Weir· University Hospital

The ALIGN study is a Phase 3, randomized, double-blind trial evaluating the efficacy and safety of atrasentan, a selective endothelin A receptor antagonist, in patients with biopsy-proven IgA nephropathy at risk of progressive renal function loss. Participants receive 0.75 mg of atrasentan or placebo daily for 132 weeks while maintained on a maximally tolerated, stable dose of a RAS inhibitor. The study population includes a primary cohort of approximately 320 patients and a separate stratum for those on stable SGLT2i therapy. The primary endpoint is the change in proteinuria as measured by UPCR, with secondary outcomes assessing kidney function via eGFR slope and overall safety.

Andrew House· University Hospital

This Phase III, randomized, multicentre, double-blind study evaluates the efficacy, safety, and tolerability of a zibotentan/dapagliflozin combination compared to dapagliflozin monotherapy. The study population includes patients with CKD and high proteinuria, specifically targeting those who remain at risk despite standard care. The primary objective is to determine if the addition of zibotentan, a selective endothelin A receptor antagonist, to the SGLT2 inhibitor dapagliflozin further reduces albuminuria. Researchers monitor changes in UACR and eGFR as key indicators of renal function and treatment response.

Matthew Weir· University Hospital

This Phase II-III multi-center randomized controlled trial evaluates whether urinary CXCL10 monitoring to detect and treat early subclinical rejection improves outcomes in adult renal transplant recipients. Patients with confirmed elevations in urinary CXCL10 between 2 weeks and 9 months post-transplant are randomized 1:1 to either an intervention arm or a standard-of-care control arm. The intervention group undergoes a renal biopsy for elevated CXCL10 levels, with biopsy-proven rejection treated per protocol, while the control group receives routine surveillance based on serum creatinine and proteinuria. All randomized participants undergo a protocol biopsy at 12 months to assess primary and long-term allograft outcomes.

Lakshman Gunaratnam· University Hospital

The CARSK trial evaluates whether eliminating routine, non-invasive coronary artery disease (CAD) screening after waitlist activation is non-inferior to standard periodic screening for preventing major adverse cardiac events. The study population consists of asymptomatic kidney transplant candidates with ESRD who have already undergone initial screening for waitlist entry. Participants are randomized to either no further CAD screening until transplantation or regular screening at annual intervals. Secondary outcomes include the rate of transplantation and the relative cost-effectiveness of each strategy. This trial addresses the lack of evidence supporting the current practice of repetitive cardiac testing in patients awaiting renal replacement therapy.

Dervla Connaughton· University Hospital

This Phase 2a randomized, double-blind, placebo-controlled study evaluates the efficacy and safety of BAY 3401016 in adults aged 18 to 45 with rapidly progressing Alport Syndrome. The intervention is a monoclonal antibody that targets Semaphorin 3A (Sema3A), a protein implicated in the pathogenesis of glomerular damage and progressive renal decline. The primary objective is to determine if Sema3A inhibition reduces proteinuria and slows the loss of kidney function in this population. Investigators monitor changes in UACR and eGFR to assess the drug's impact on disease progression. The trial includes an initial treatment phase followed by an extension phase to evaluate long-term safety and clinical outcomes.

Pavel Roshanov· University Hospital

Prospective cohort to evaluate the dialytic clearance of tranexamic acid.

Matthew Weir· University Hospital

This observational, non-interventional cohort study evaluates the real-world impact of tolvaptan in Canadian patients with ADPKD. The study assesses the burden of illness through patient-reported outcome questionnaires and tracks clinical progression to RRT, including dialysis and transplantation. Researchers monitor long-term mortality rates and specific causes of death, with a focus on renal and hepatic outcomes. The target population consists of ADPKD patients prescribed tolvaptan as part of routine clinical care following Health Canada approval.

Lakshman Gunaratnam· University Hospital

Patients can be seen at: University Hospital

This Phase 2, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of ALXN2030 in adult kidney transplant recipients with biopsy-proven active or chronic active antibody-mediated rejection (AMR). Participants are randomized 1:1:1 to receive ALXN2030 Dose A, ALXN2030 Dose B, or placebo for 52 weeks in addition to standard of care immunosuppression. The primary objective is to assess histologic resolution of AMR via repeat allograft biopsies at 28 and 52 weeks. Secondary outcomes include pharmacokinetics, immunogenicity, and long-term safety during a 52-week open-label extension.

Lakshman Gunaratnam· University Hospital

This Phase 2, global, multicenter, randomized, double-blinded, placebo-controlled trial evaluates the safety, tolerability, and efficacy of efgartigimod PH20 SC in kidney transplant recipients experiencing antibody-mediated rejection (AMR). Participants are randomized 1:1:1 to receive subcutaneous efgartigimod PH20 via prefilled syringe or placebo for a 48-week treatment period. All participants remain on standard background immunosuppression, including tacrolimus, mycophenolate mofetil, and steroids. The study monitors clinical outcomes and safety over a total duration of 78 weeks, including a 24-week observational follow-up period. The primary objective is to determine if neonatal Fc receptor (FcRn) inhibition effectively manages AMR in this patient population.

Matthew Weir· University Hospital

This Phase 3, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of ianalumab as an add-on to standard-of-care therapy in adults with active lupus nephritis. c. c. q12w, or placebo. The primary objective is to assess the impact of B-cell depletion via ianalumab on clinical response rates, typically measured by improvements in UPCR and stabilization of eGFR.

Matthew Weir· University Hospital

This randomized, controlled trial evaluates the efficacy and safety of iptacopan, an oral factor B inhibitor, for inducing and maintaining remission in patients with newly diagnosed or relapsed active GPA or MPA. Participants receive iptacopan or placebo in combination with a rituximab induction regimen. The study assesses primary outcomes related to clinical remission and secondary endpoints including disease relapse rates, GC-related toxicity, and changes in eGFR and UPCR. The target population includes patients with active ANCA-associated vasculitis requiring induction therapy.

Matthew Weir· University Hospital

This Phase 3, multicenter, randomized, double-blind trial evaluates the efficacy and safety of iptacopan, an oral complement alternative pathway inhibitor, in adult and adolescent patients with native C3 glomerulopathy. Participants are randomized to receive either iptacopan or placebo in addition to standard of care to assess the drug's impact on proteinuria and renal function. The primary endpoints include the reduction in UPCR and stabilization of eGFR compared to placebo at the end of the treatment period. Secondary objectives utilize serum C3 levels and repeat kidney biopsies to evaluate the inhibition of the alternative pathway and associated histopathological improvements.

Pavel Roshanov· University Hospital

REPAIR is a Phase 1 open-label basket trial evaluating the safety and tolerability of colchicine in patients with CKD or ESRD requiring maintenance dialysis. Participants receive 0.3 mg of colchicine daily for 8 weeks, followed by a forced titration to 0.6 mg daily for an additional 8 weeks in those who tolerate the initial dose. The primary objective is to determine the proportion of patients in each cohort who discontinue treatment at both the 0.3 mg and 0.6 mg dose levels. The study aims to establish a feasible dosing regimen for future investigations into reducing cardiovascular injury via inflammation reduction in this high-risk population.