Research The Renal program is committed to improving the quality of renal care and is actively involved in the research community. Following are some of the studies that were commenced, on-going, or completed in 2015/16. Table 10.1 Summary of Research in Renal Program Name of Study Study Lead(s) Hypothesis/ Objective # of patients enrolled End date or C Canadian Medical Assessment of JINARC™ Dr. S Soroka, Dr. Penelope Poyah Registry study for ADPKD on Jinarc Not yet started but to enroll 50 Industry Medication Reconciliation in the Clinic Amany Aly, Holly Carver, Dr. Jo-Anne Wilson, Marsha Wood, Dr. Penelope Poyah, Matt Phillips, Cindy Everett, Anne Hiltz A retrospective analysis of the impact of medication reconciliation in the Renal Clinic to determine the patient safety impact of medication reconciliation. 100 2016 CDHA pharmacy research CFDI Canadian Fabry disease Initiative Dr. M. West Prospective of enzyme replacement therapy in Fabry disease 420 Oct 1 2016 Provincial sponsored LAL-CL06 Dr. M. West Study of Sebilipase enzyme replacement therapy in lysosomal lipase deficiency 1 2017 Industry
The PARROT study: 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 chornic renal insufficiency Dr. Steven Soroka, Dr. Jo-Anne Wilson, Ms. Susan Fleet To determine the safety and efficacy of Fragmin to prevent clotting in the extracorporeal system during hemodialysis, when Fragmin is administered according to the adjustable dose regimen. 15 2016 Industry Effectiveness and cost of weekly in hemodialysis patients at high risk of catheter complications: Quality Assurance Project of the implementation and evaluation of the PreCLOT. Dr. Steven Soroka, Dr. Jo-Anne Wilson, Dr. Karthik Ms. Paula Mossop To determine, in real world clinical practice among outpatient hemodialysis patients with a CVC who are at high risk of catheter malfunction, if use of rtPA once per week compared to citrate as a locking solution results in: 1) a reduction in the rate of rt-PA use for treatment of catheter malfunction ; 2) a reduction in the rate of catheter-related bacteremia; 3) a reduction in the rate of radiological interventions for catheter malfunction ;and 4) a reduction in cost and hospitalizations 100 2016 Both industry and funded An Evaluation of hepatitis B Vaccine Seroconversion in Predialysis Chronic Kidney Disease and Hemodialysis Patients: A Dr. Jo-Anne Wilson, Dr. Steven Soroka,Dr. Karthik Tennankore, Dr. Bryce Kiberd, Dr. Shelly MacNeil, The objectives are to determine: 1) whether patients (matched for characteristics that have been shown to influence response rates to Hepatitis B vaccine) with CKD stages (predialysis) have better seroconversion rates compared to hemodialysis 800 HD, 50 Tennankore
administering Alteplase (Cathflo) CFDI Canadian Fabry disease Initiative Dr. M. West Prospective study of enzyme replacement therapy in Fabry disease 440 Oct 1 2016 Provincial sponsored LAL-CL06 Dr. M. West Study of Sebelipase enzyme replacement therapy in lysosomal lipase deficiency 1 2017 Industry sponsored FOS: Fabry Outcome Survey Dr. M. West Registry collecting clinical data on Fabry patients. 72+ open Shire HGT Fabry Registry Dr. M. West Registry collecting clinical data on Fabry patients. 76+ open Genzyme Gene Transfer Therapy in Fabry Disease Dr. M. West A gene therapy clinical study directed towards amelioration of Fabry disease in men using Lentivirus-transduced, autologous CD34+ stem cells will demonstrate safety and feasibility. 0 2021 CIHR sponsored REP-081 Dr. M. West A III clinical to determine the safety of a new form of agalsidase-alfa enzyme replacement therapy in Fabry disease. 40 open HGT CS4 Study: A Phase 2, Randomized, Double Blind, Placebo Controlled Study of the Safety, Pharmacokinetics, and of Multiple Dr. K. Tennankore Dr. Kiberd, Dr. Soroka The overall objectives are to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS 416858 in ESRD patients on hemodialysis 4 industry
Doses of ISIS 416858 an Antisense Inhibitor of Factor XI), Administered Subcutaneously to Patients with Renal Disease on Hemodialysis Frailty and the Transplant Waitlist Dr. K. Tennankore, Dr.Kiberd, Dr. West, Dr. Dr.Alwayn, Sills, etc To determine if frailty (using the Fried Frailty Phenotype Assessment) is associated with a higher risk of death or permanent withdrawal from the transplant waitlist. 68 FIDELIO-DKD (16244): A randomised, double-blind, parallel-group, multicenter, event-driven phase III study to investigate the efficacy and safety of finerenone, in addition to standard of care, on the progression of kidney disease in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease. Dr. K. West, Soroka) Demonstrate whether, in addition to standard of care (SoC),finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of eGFR ≥ 40% from baseline over at least 4 death weeks or renal 0 Industry controlled,