Current studies

CanPREDDICT: Canadian study of Prediction of Risk and Evolution to Dialysis, Death and Interim Cardiovascular events over Time
Principal Investigator: Adeera Levin (SPH), Nadia Zalunardo (VGH), Janis Dionne (CW)
Funding sponsor: Ortho Biotech Inc.

The goal of the study is to identify a set of blood and urine tests that will act as a tool to help doctors identify individuals or populations who are at risk for progression of kidney disease.People with chronic kidney disease are also at a higher risk for Cardiovascular Disease (CVD).The study will also be looking to see if there are blood and urine markers to predict the progression of heart and vessel disease.

Substudy: Bioimpedance as a predictor of cardiovascular outcomes in patients with chronic kidney disease
Funding sponsor: Kidney Foundation of Canada

In people with chronic kidney disease, fluid overload is common and is associated with poor health outcomes.Currently, clinical assessment of the amount of fluid a person has in their body is inexact.The purpose of this sub-study is to gain a better understanding about the usefulness of bioimpedance testing. Bioimpedance testing is used to determine the amount of extra fluid that a person may have in their body. The future goal is to develop bioimpedance measurement into a clinical tool that will allow doctors to more accurately assess fluid status in patients with chronic kidney disease.

The ‘PEXIVAS’ Trial: Plasma exchange and glucocorticoid dosing in the treatment of anti-neutrophil cytoplasm antibody associated vasculitis: an international randomized controlled trial.
Principal Investigator: Adeera Levin
Co-Investigators: Michael Copland, Monica Beaulieu, Ronald Werb, Nadia Zalunardo, Jacek Jastrzebski, Gayatri Sreenivasan, Mercedeh Kiaii, Jagbir Gill, Choi Kit Yeung, Suneet Singh
Sponsor Investigator: Michael Walsh, McMaster University, Hamilton, ON
Funding Sponsor: Canadian Institute of Health Research

This trial aims to study the combination of Plasma Exchange and either standard-dose or reduced-dose glucocorticoids in the treatment of ANCA-associated vasculitis. Eligible patients with ANCA-associated vasculitis are randomized 1:1 to receive Plasma Exchange/No Plasma Exchange, then within each PLEX group, randomized 1:1 to receive standard dose / reduced dose glucocorticoids. Participants will also receive standard immunosuppressive therapy. The follow-up period for all patients will be between 5 and 7 years duration. The primary outcome measure will be time to the composite endpoint of all-cause mortality or end-stage renal disease. This trial is a large, multi-centre, international randomized controlled trial coordinated centrally out of the Birmingham Clinical Trials Unit, on behalf of the European Vasculitis Study Group (UK) and the Vasculitis Clinical Research Consortium (USA).

Substudy: Fibrocytes in Glomerulonephritis (FIG)
Sponsor Investigator: Peter Margetts, McMaster University, Hamilton, ON

This is an observational study to help us understand what cells are drawn to the kidney in patients with an acute deterioration in renal function due to glomerulonephritis. We will take your blood and use an assay called ‘flow cytometry’ to count the number fibrocytes in the blood. From the initial blood sample, we will also grow fibrocytes in a dish and see how your cells respond to injury.

The impact of vitamin D supplementation on vascular stiffness and blood pressure in Chronic Kidney Disease patients
Principal Investigator: Adeera Levin
Co-Investigators: Mhairi Sigrist, Ognjenka Djurdjev, Monica Beaulieu, Michael Copland, Mercedeh Kiaii, Nadia Zalunardo, Peter Neufeld
Funding Sponsor: Unrestricted Educational Grant- Kidney Foundation of Canada & Pfizer

The purpose of this study is to investigate whether providing vitamin D as a medication can have a direct affect on the stiffness of the blood vessels.The findings of this study will help both physicians and dietitians decide weather vitamin D therapy is beneficial to patients and should help decide which type of vitamin D is best to give to people with chronic kidney disease (CKD).We expect 125 people from St. Paul’s and Vancouver General Hospital attending the kidney function clinic will participate in this study.

BK Viremia: Kinase Inhibition to Decrease Nephropathy Intervention
Principal Investigator: Jean Shapiro
Co-Investigators: Olwlyn Johnston, Paula Kebarle, Nilu Partovi, Trana Hussaini
Sponsor Investigator: Lee Anne Tibbles, University of Calgary
Funding Sponsor: Canadian Institutes of Health Research

This Clinical Trial is being conducted to determine whether reduction of immunosuppression or combination therapy with leflunomide and sirolimus is a better treatment for patients who develop reactivation of BK virus in their bloodstream. We hope to discover which treatment results in better kidney graft survival, less rejection, better kidney function, better clearance of the BK virus and fewer side effects.

The BC Glomerulonephritis Registry
Principal Investigator: Sean Barbour
Funding Sponsor: BC Renal Agency

The substantial knowledge gaps in GN, the risk of progression to ESRD, and the presumed considerable health burden of these rare diseases all underscore the potential benefits of the BC GN Registry, a unique system that will be the first of its kind in Canada and will register all patients with biopsy-proven GN within the existing health services CKD infrastructure with longitudinal capture of laboratory and clinical data. However, there is currently no available information on the incidence, management or outcome of GN patients in BC, thereby preventing a rigorous development process for the BC GN Registry. The purpose of this project is to link administrative datasets to address specific research questions that will describe the provincial experience with GN over the last 12 years in BC. These results will both address important clinical research questions, and provide the critical background data that will justify the need for and facilitate the future development of the BC GN Registry.

Pharmacokinetics and Pharmacogenetics of Mycophenolate: Prediction of Neutropenia in Steroid-Free Renal Transplant Recipients
Principal Investigator: Mary Ensom
Co-Investigators: Jean Shapiro, Nilufar Partovi, Tony Kiang, Erica Greanya

The purpose of this study is to improve mycophenolate therapy in kidney transplant recipients by finding out if too much mycophenolate in the body is related to the severe side effect of reduced neutrophil count.The specific goals for the study are:

  • To determine if low neutrophil count is the result of too much mycophenolate exposure.
  • To determine if mycophenolate exposure can predict neutrophil levels.
  • To find out if patient-specific factors (e.g. age, sex, weight, concurrent medications, genetic makeup, etc.) can influence mycophenolate exposure and/or the occurrence of low neutrophil count.

As tacrolimus (another immunosuppressive agent) is frequently prescribed at the same time with mycophenolate, we will determine if tacrolimus exposure (to be estimated using a method that we developed which only requires 2 blood samples) is also related to reduced neutrophil count. We will also determine if differences in genetic make-up of enzymes that break down mycophenolate (e.g. UDP-glucuronosyltransferase (UGT) and ATP-binding cassette sub-family C member 2 (ABCC2)) can influence mycophenolate exposure or lowered neutrophil count.

Screening for Fabry disease in a high-risk population with chronic kidney disease
Principal Investigator: Adeera Levin
Co-investigator: Sean Barbour
Sponsor Investigator: Christiane Auray-Blais, University of Sherbrooke, QC
Sponsor Funding: Genzyme Canada

A new screening test is now available for screening high-risk populations for Fabry disease.We propose to use this test for screening in a population which is at risk as this may accelerate the diagnosis of the disease in both men and women.Early diagnosis is now considered to be essential to prevent the development of irreversible tissue damage. Early detection is also important for genetic counseling.

Evaluation of heparin anticoagulation protocol in post-renal transplant recipient
Principal Investigator: Marianna Leung
Co-investigators: Joan Ng, David Landsberg, Gary Nussbaumer, John Gill, Jagbir Gill, Clare Bannon

Primary Objectives: To compare the incidences of major and minor bleeding complications between post-transplant recipients receiving therapeutic anticoagulation (e.g. UFH and LMWH) and those receiving thromboprophylaxis.

Secondary Objectives:

  • To determine the coagulation parameters around the bleeding episodes between post-renal transplant patients receiving therapeutic vs prophylactic heparin
  • To determine the potential contributing risk factors to bleeding between post-renal transplant patients receiving therapeutic vs prophylactic heparin
  • To determine if any interventions were required to treat complications
  • To determine the indication for heparin and its efficacy

Comparison of medication adherence between once daily tacrolimus (Advagraf®) and twice daily tacrolimus (Prograf®) administration in stable renal transplant recipients – a randomized study
Principal Investigator: Jean Shapiro
Co-Investigators: Wendy Loken Thornton, Nilufar Partovi, Theone Paterson, Maryam Demian, Paul Keown, Olwyn Johnston, Paula Kebarle, Trana Hussaini,
Funding Sponsors:Astellas Pharma Canada Inc.

This study has two primary goals. The first is to examine psychological variables (the roles of mood, personal attitudes, problem-solving, and memory abilities) in predicting medication adherence in renal transplant recipients. The second is to examine whether use of once per day tacrolimus (Advagraf®) versus use of twice daily tacrolimus (Prograf®) will have any influence on medication adherence in renal transplant recipients.

A Multi-center, Longitudinal, Observational Study of Patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD) to Establish the Rate, Characteristics and Determinants of Disease Progression
Principal Investigator: Monica Beaulieu (SPH), Nadia Zalunardo (VGH)
Co-Investigator: Adeera Levin, Paul Taylor, Kit Yeung
Funding Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

The purpose of this international study is to collect information that is usually collected in the context of the treatment and management of ADPKD. The data will allow the investigators to understand the treatment and other factors that have an effect on disease progression.  This study may lead to future research objectives.If this happens you will not benefit financially from products that are developed as a result of this study.

Membranous Nephropathy Trial Of Rituximab (MENTOR):  A Randomized Controlled Trial of Rituximab versus Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy (IMN).
Principal Investigator: Sean Barbour
Co-investigator: Adeera Levin
Sponsor Investigator: Fernando Fervenza, Mayo Clinic Rochester, University of Toronto
Funding Sponsor: Genentech, Incorporated

You are being asked to take part in this research study to determine if the drugs, either rituximab or cyclosporine can help your kidney disease by reducing the amount of protein in your urine. Rituximab, also called Rituxan®, works by removing temporarily a cell in the body (a specific type of B-cell) which is thought to be important in causing damage to your kidney. It is currently approved for use in rheumatoid arthritis (stiffness and inflammation of the joints) and ANCA Associated Vasculitis (inflammation of blood vessels). Cyclosporine is a drug used in kidney transplantation to suppress your immune system and therefore avoid rejection. It also reduces your body’s ability to make antibodies, which are proteins that normally detect and fight infection, but they can also deposit in your kidney, injure its filter and cause it to leak protein into the urine.

Neither cyclosporine nor rituximab have Health Canada (HC) or Food and Drug Administration (FDA) approval for routine clinical use or for the use described in this study. However HC and the FDA have both allowed the use of this drug in this research study. Both drugs have been used successfully not only in this type of kidney disease but also in the field of kidney transplantation.

We are conducting this study in 20-30 teaching hospitals and kidney centers across the United States and Canada. The plan is to have a total of 126 patients in the study with approximately 6 – 10 coming from St. Paul’s Hospital.

Blood pressure guided biofeedback on hemodialysis and the reduction of intradialytic hypotensive episodes:  A randomized cross over trial (BP-RIDH)
Principal Investigator: Mercedeh Kaii
Co-investigator: Beverly Jung, Jennifer MacRae

The purpose of this study is to determine if blood pressure guided biofeedback software that is added to your current hemodialysis machine, can lower the number of hypotensive episodes and can lower the amount of uncomfortable feelings that occur when the blood pressure is low. The standard treatment for subjects who are eligible for this study is to continue on their regular hemodialysis without this software added (no biofeedback). The intervention treatment is the same hemodialysis but with the biofeedback software turned on. This software is Health Canada approved, has previously been tested on patients and is currently in use at many different hemodialysis units, including the East Vancouver Hemodialysis Unit. However, we would like to determine how well this software can reduce the number of low blood pressure episodes amongst our patients at St Paul’s Hospital hemodialysis unit.

Effect of Immunosuppressive Medication Use on Patient Outcomes Following Kidney Transplant Failure
Principal Investigator: John Gill (SPH), Olwyn Johnston (VGH)
Co-investigator: Jagbir Gill, David Landsberg, Gary Nussbaumer
Funding Sponsor: Canadian Institutes of Health Research

This study will observe patients and collect information about the use of anti-rejection medication and / or surgery (nephrectomy) after kidney transplants stop working. We will be examining any link between these treatments and possible health outcomes such as infection, death and kidney rejection. We also wish to determine the impact of these treatments on allosensitization (the formation of proteins in blood) and how it might affect the chances of a repeat transplantation. The information we learn in this study will help us design the best way to care for patients with non-functioning kidney transplants in the future. Since no study to date has carefully examined this patient group, questions remain about how best to manage the non-functioning kidney transplant.

Long-term Effects of Becoming a Living Kidney Donor Study
Principal Investigator: John Gill
Co-investigator: Jagbir Gill, David Landsberg, Gary Nussbaumer
Funding Sponsor: Canadian Institutes of Health Research

The main goals of this study are to better understand:

  • The long-term medical effects of donating a kidney (high blood pressure, protein in the urine and kidney function)
  • The psychological effects of donating a kidney
  • The financial costs of being evaluated for donation

We will use information from this study to improve the transplant decision-making process, informed consent, health policies, and the follow-up of living kidney donors to keep them in good health.

ACE-Inhibition for the Preservation of Renal Function and Patient Survival in Kidney Transplantation
Principal Investigator: John Gill, Jean Shaprio
Co-investigator: David Landsberg, Gary Nussbaumer, Paul Keown, Olwyn Johnston
Funding Sponsor: Ottawa Hospital Research Institute

The purpose of this study is to determine whether the ACE-inhibitor, Ramipril, will slow the progression of renal disease and prolong survival for kidney transplant recipients with chronic kidney disease.

This will be determined by measuring the time from kidney transplantation to:

  • A doubling of serum creatinine (a compound present in the muscles and blood that is used as a marker of kidney health)
  • Onset of End-stage renal disease
  • Death

A prospective, open label, pilot study comparing the use of low-target Advagraf with rabbit antithymocyte globulin induction versus conventional target Advagraf with basiliximab induction in a steroid-avoidance immunosuppressive protocol for de novo renal transplant recipients
Principal Investigator: Jagbir Gill
Co-investigator: John Gill, David Landsberg, Gary Nussbaumer, Olwyn Johnston, Paul Keown, Jean Shapiro
Funding Sponsor: Astellas Pharma Canada, Inc.

This study has been designed to test whether using Thymoglobulin with low dose tacrolimus and early steroid withdrawal will minimize both kidney rejection and the development of new onset diabetes after transplant. This pilot study plans to enroll 30 patients between St. Paul’s Hospital and Vancouver Hospital. The purpose of a pilot study is to determine the feasibility and benefit of doing a larger study. Your participation will help to determine the usefulness of this new combination of anti rejection drugs

Controlled, Randomized, Prospective, Double-Blind, Multicenter, Phase I/II, Dose-Escalation Study of the Safety, PK, and Clinical Activity of I5NP for Prophylaxis of Delayed Graft Function in Patients Undergoing Deceased Donor Kidney Transplantation
Principal Investigators: Jagbir Gill, Olwyn Johnston
Co-Investigators: Jean Shapiro, Chris Nguan
Funding Sponsor: Quark Pharmaceuticals, Inc.

The purpose of this study is to see if an experimental drug, I5NP, is safe and could be used to prevent DGF. An experimental drug is one that has not been approved for marketing by the U.S. Food and Drug Administration (FDA) or Health Canada. It can only be used for testing in clinical studies. This experimental drug has been tested in animals, and as of spring 2010, I5NP has been given to approximately 45 subjects in three clinical studies. In 2009, 32 patients undergoing kidney transplant surgery received I5NP. A group of independent doctors and other professionals have reviewed the safety data for all 32 patients and have agreed that further studies can be conducted with this experimental drug.

Transfusion ManagEMent of Incident Dialysis Patients in Canada: A Prospective Observational Study (TEMPO)
Principal Investigator: Mercedeh Kaii
Co-Investigators: Jacek Jastrzebski, John Gill
Funding Sponsor: Amgen

The purpose of this study is to learn more about the frequency of red blood cell units transfused in the new hemodialysis patient population in Canada.

Longitudinal comparison of quality of life among kidney transplant recipients and nocturnal home hemodialysis patients.
Principal Investigator: Michael Copland
Co-Investigator: Myriam Farah
Funding Sponsor: Canadian Institutes of Health Research

This research study will investigate the quality of life of patients undergoing nocturnal hemodialysis compared to patients who received a kidney transplant. Results of this study will be very important in counseling kidney disease patients regarding their treatment options.

Quinolone Prophylaxis for the Prevention of BK Virus Infection in Kidney Transplantation:  A Pilot Study
Principal Investigator: John Gill
Co-Investigators: Jagbir Gill, David Landsberg, Gary Nussbaumer, Paul Keown, Olwyn Johnston
Funding Sponsor: The Ottawa Hospital Research Institute (OHRI) and Canadian Institutes of Health Research (CIHR)

Quinolone antibiotics, such as levofloxacin, can reduce the growth of BK virus. We think that giving a quinolone antibiotic soon after transplantation will prevent the BK virus from developing in the urine and blood stream.  The quinolone antibiotic levofloxacin has been approved by Health Canada and is commonly used to treat infections such as bacterial pneumonia.  However, in this study levofloxacin is being used experimentally for the purpose of preventing a virus. The main purpose of this pilot project is to assess the usefulness, safety and feasibility of giving a 3-month course of levofloxacin to kidney transplant patients.

Specifically, this pilot study will determine: (1) whether levofloxacin can lessen the rate of getting BK virus in urine and blood; (2) the number of side effects that happen during a 3-month course of levofloxacin; (3) how well patients are able to complete the 3-month course of levofloxacin; and (4) how many patients choose to stop being part of the study. This information will be used to help us plan a larger study in the future.

This study is important because how doctors treat patients early after kidney transplantation impacts on how well the transplanted kidney can filter the blood and keep patients healthy. No study to date has proven the best way to prevent BK virus after kidney transplantation. The information we learn in this study will help us determine the best way to care for patients with kidney transplants in the future.

Studies in Development

The CKD-FIX Study: a randomized Controlled trial of slowing of Kidney Disease progression From the Inhibition of Xanthine oxidase.
Principal Investigator: Adeera Levin
Sponsor Investigator: David Johnson
Funding Sponsor: National Health and Medical Research Council, Australia, Canadian Institute of Health Research

The primary aim of the study is to test the hypothesis that uric acid lowering therapy with the xanthine oxidase (XO) inhibitor, allopurinol, will significantly slow kidney failure progression in patients with moderate chronic kidney disease (CKD). 620 adult participants with CKD stages 3 or 4 who have experienced rapid progression of their CKD over the preceding 12 months will be recruited to the trial. Participants will be randomized 1:1 to receive 100-300 mg of allopurinol daily (dose dependent on CKD stage and tolerance), and treatment will be blinded to participant and treating team. The primary outcome measure will be an assessment of eGFR throughout and at the end of the 24 month treatment period as a marker of CKD progression, and a series of secondary outcomes related to blood pressure, proteinuria, cardiovascular events and death will also be measured.

Predicting mortality, technique survival, and training failure for a Canadian multicentre home hemodialysis cohort
Principal Investigator: Michael Copland
Co-Investigator: Paul Komenda
Sponsor Investigator: Robert Pauly

Therapeutic Evaluation of Steroids in IgA Nephropathy Global  (TESTING) Study - Canadian Network
Principal Investigator: Sean Barbour
Co-investigator: Adeera Levin
Sponsor Investigator: Michelle Hladunewich, University Health Network
Funding sponsor: Canadian Institutes of Health Research

This study is being conducted to clearly understand what benefits and risks are associated with corticosteroids in IgA nephropathy, using a corticosteroid called methylprednisolone. Health Canada has not approved methyprednisolone (Medrol®) for use or sale for IgA nephropathy although they have allowed its use in this research study.

SONAR: Study Of Diabetic Nephropathy with Atrasentan. A Randomized, Multicountry, Multicenter, Double‑Blind, Parallel, Placebo-Controlled Study of the Effects of Atrasentan on Renal Outcomes in Subjects with Type 2 Diabetes and Nephropathy
Principal Investigator: Adeera Levin
Funding Sponsor: AbbVie Corporation Inc.

The purpose of this study is to evaluate whether or not atrasentan is effective in delaying the time to the onset of end stage renal disease in subjects like you with type 2 diabetes and kidney disease. Another purpose of this study is to test the safety of atrasentan. In addition, this study will compare atrasentan with a placebo to see if taking atrasentan is better than taking a placebo. The placebo is a tablet that looks like a drug but has no drug or other active ingredient in it.

Effect of lowering the dialysate sodium on blood pressure in hemodialysis patients:  A randomized controlled trial.
Principal Investigator: Nadia Zalunardo
Sponsor Investigator: Rita Suri & Robert Lindsay. London Health Sciences Centre
Funding Sponsors: Canadian Institutes of Health Research, Kidney Foundation of Canada, Division of Nephrology, London Health Sciences Centre

The purpose of this study is to study the effect of lowering the sodium level in the dialysate on your blood pressure. As you know, hemodialysis is a way to remove excess fluid and toxins from the blood when the kidneys are not working.During hemodialysis, a person’s blood goes through a filter on the hemodialysis machine.Also going through the filter is the dialysate – a fluid that contains sodium, calcium, magnesium, potassium, and glucose.When the blood meets the dialysate in the filter, fluid and toxins are removed from the blood and go into the dialysate.However, some electrolytes, including sodium, may also be transferred from the dialysate into the blood.As you may know, higher sodium levels in the body can lead to high blood pressure. Doctors wish to study whether lowering the sodium level in the dialysate will reduce the amount of sodium in the body, thus leading to better blood pressure control.

Novel Endovascular Access Trial” (NEAT):  A Study of the FLEX System for Percutaneous AV Fistula Creation in Hemodialysis Patients
Principal Investigator: Mercedeh Kiaii
Co-Investigator: Beverly Jung
Funding Sponsor: TVA Medical, (the manufacturer of the device)

The purpose of this research study is to study the safety and efficacy of the FLEX device for creation of an AVF for vascular access. The FLEX device creates an AVF in a non-surgical fashion (meaning no surgical operation is required). This is done by the insertion of catheters through your skin into an artery and a vein and joining them using Radiofrequency (Rf) energy (which is similar to a Bovie electrode that is used to cut and clot tissue). The FLEX device is experimental but is meant to be easier on you because it does not require surgery. This means that Health Canada has not approved the sale or use of the FLEX device but they have approved its use in this research study.

Peritoneal Dialysis Outcomes And Practice Patterns Study (PDOPPS)
Principal Investigator: Paul Taylor
Funding Sponsor: Arbor Research

The purpose of this study is to improve the treatment, quality of life, and survival of patients receiving peritoneal dialysis. This study is called the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) and will collect medical information on thousands of peritoneal dialysis patients in multiple countries. Your dialysis unit is participating in this study, which uses funding provided by unrestricted research grants from Baxter, Fresenius, The Japanese Society of Peritoneal Dialysis, local government, and grants. It is coordinated by Arbor Research Collaborative for Health.

A phase IIIb open label study to optimize the single bolus dose of dalteparin sodium for the prevention of clotting within the extracorporeal system during hemodialysis procedures for subjects with chronic renal insufficiency: The PARROT study
Principal Investigator: Mercedeh Kiaii
Co-investigator: Beverly Jung
Funding Sponsor: Pfizer, Inc.

The purpose of this research study is to learn about the safety and effect of flexible dosing of dalteparin sodium (FRAGMIN®), the study drug, in preventing clotting during up to 4 hours of HD.  In this study, this will be done by comparing FRAGMIN® given as a fixed dose (5000 Internationalized Units [IU]) during the first HD session and then given as an adjusted or flexible dose (adjusted by 500 IU or 1000 IU) as needed for the remaining HD sessions.

Alteration of the Microbiome in IgA Nephropathy
Principal Investigator: Sean Barbour
Co-Investigator: Adeera Levin
Sponsor Investigator: Heather Reich
Sponsor Funding: Integrating Challenge Grant, Department of Medicine, University of Toronto

The goal of this project is to determine if IgA nephropathy (IgAN) is triggered by infections or changes in the balance of “normal” bacteria that inhabit humans. Emerging research suggests that disruption in this balance of bacteria in the body is a trigger for diseases of the immune system. However it is not known whether this may play a role in the development of IgAN. Compelling new data suggest that this is possible

Vanguard Multi-centre feasibility trial to determine if buttonhole versus step-ladder cannulation for high dose hemodialysis is associated with reduced overall cost: A pilot study
Principal Investigator: Michael Copland
Co-Investigator: Adeera Levin, Suneet Singh, Peter Neufeld, John Duncan, Nadia Zalunardo, Paul Taylor, Abeed Jamal
Sponsor Investigator: Deborah Zimmerman, Ottawa Hospital Research Institute
Funding Sponsor: Baxter Healthcare Incorporation

The main purpose of this pilot study is to determine:

  • How feasible it is to randomize patients to step-ladder versus buttonhole needling techniques, and
  • Coordinating the multiple Canadian sites that are required for the definitive study.

The secondary purpose of this study is to determine:

  • If buttonhole needling technique, compared to step-ladder needling technique is associated with reduced AVF complications
  • If buttonhole needling technique, compared to step-ladder needling technique is associated with reduced patient discomfort with needling.

Virtual ward for home dialysis – A novel model to address transitions of care
Principal Investigator: Michael Copland
Co-Investigator: Adeera Levin, Suneet Singh, Peter Neufeld, John Duncan, Nadia Zalunardo, Paul Taylor, Abeed Jamal
Sponsor Investigator: Christopher Chan, University Health Network
Sponsor Funding: Baxter Investigator Initiated Research Grant Program

This study will look at a program called Virtual Ward for Home Dialysis. In this program, you will receive calls from the Nephrology team on a regular basis for a minimum of two weeks in an effort to identify areas of your care that should be identified sooner than later. It is believed that this will avoid interruptions in your care that could have negative consequences.

Study of Losmapimod to Reduce Proteinuria in Corticosteroid or Calcineurin Inhibitor Resistant Idiopathic Focal Segmental Glomerulosclerosis (FSGS)
Principal Investigator: Sean Barbour
Funding Sponsor: GlaxoSmithKline

This is a single-arm, multicenter, open-label Phase II, proof-of-mechanism study to evaluate the efficacy, safety, tolerability and pharmacokinetics of losmapimod in approximately 21 subjects with primary (idiopathic) focal segmental glomerulosclerosis (FSGS). FSGS patients with nephrotic range proteinuria (urinary protein/creatinine [Up/c] ratio > 3) and a history of steroid or calcineurin inhibitor resistance, including relapse of proteinuria after steroid or calcineurin inhibitor treatment will be included. Losmapimod will be orally administered twice daily over a 24-week treatment phase followed by a 12-week follow-up for safety and relapse assessments. The effect of losmapimod on pharmacodynamic markers, FSGS symptoms, and the primary efficacy endpoint of proteinuria will be evaluated. Safety and tolerability will be closely monitored by clinical laboratory evaluations (including liver function tests and serum creatinine), vital signs, ECGs, and assessment of adverse events. The pharmacokinetics of losmapimod and the metabolite GW198602 will also be determined.

BC Tolvaptan and Hyponatremia registry
Principal Investigator: Sean Virani
Co-Investigator: Monica Beaulieu
Funding Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Objectives are:

  • Educate cardiology, nephrology community in appropriate usage for Tolvaptan
  • Establish a formal process (standardized algorithm) to assess appropriate usage for Tolvaptan in hyponatremia in-patients in BC
  • Capture hyponatremia cases via registry and follow outcomes at 3 and 6 months either with or without Tolvaptan treatment for comparison
  • Build business case to approach formularies and drug subsidization from BCPRA or other

Establishing a ferumoxytol dosing protocol in HD patients comparing IV ferumoxytol to IV sodium ferric gluconate when given by protocol in prevalent HD patients
Principal Investigator : Monica Beaulieu
Co-Investigator : Mercedeh Kiaii
Funding Sponsor: Unrestricted grant from Amag

The purpose of this research study is to establish an evidence-based dosing protocol for Feraheme™ (ferumoxytol) injection a drug that has been approved by Health Canada for the treatment of anemia in hemodialysis patients, for both loading and maintenance dose. Compared to other intravenous iron products, ferumoxytol is has higher bioavailability, requires less time (17 second injection compared to 6 hours infusion for iron gluconate or sucrose) and frequency of dosing.