The Canadian Glomerulonephritis Registry (CGNR) and Translational Research Initiative: Rationale and Clinical Research Protocol.
Ainslie M Hildebrand, Moumita Barua, Sean J Barbour, Karthik K Tennankore, Daniel C Cattran, Tomoko Takano, Ping Lam, Sacha A De Serres, Ratna Samanta, Michelle A Hladunewich, Todd Fairhead, Penelope Poyah, D Danielle Bush, Brian MacLaren, Dwight Sparkes, Philip Boll, Arenn Jauhal, Rohan John, Carmen Avila-Casado, Heather N Reich
Author Information
Ainslie M Hildebrand: Division of Nephrology, Department of Medicine, University of Alberta, Edmonton, Canada.
Moumita Barua: Division of Nephrology, Department of Medicine, University Health Network, University of Toronto, ON, Canada.
Sean J Barbour: Division of Nephrology, Department of Medicine, The University of British Columbia, Vancouver, Canada.
Karthik K Tennankore: Division of Nephrology, Department of Medicine, Dalhousie University, Halifax, NS, Canada. ORCID
Daniel C Cattran: Division of Nephrology, Department of Medicine, University Health Network, University of Toronto, ON, Canada.
Tomoko Takano: Division of Nephrology, Department of Medicine, McGill University, Montreal, QC, Canada.
Ping Lam: Division of Nephrology, Department of Medicine, University Health Network, University of Toronto, ON, Canada.
Sacha A De Serres: Division of Nephrology, Department of Medicine, CHU de Qu��bec-Universit�� Laval, Quebec City, Canada.
Ratna Samanta: Division of Nephrology, Department of Medicine, McGill University, Montreal, QC, Canada.
Michelle A Hladunewich: Division of Nephrology, Department of Medicine, Sunnybrook Health Sciences Centre, University of Toronto, ON, Canada. ORCID
Todd Fairhead: Division of Nephrology, Department of Medicine, The Ottawa Hospital, ON, Canada.
Penelope Poyah: Division of Nephrology, Department of Medicine, Dalhousie University, Halifax, NS, Canada. ORCID
D Danielle Bush: McCarthy Tetrault LLP, Toronto, ON, Canada.
Brian MacLaren: Canadian Glomerulonephritis Registry, Toronto, ON, Canada.
Dwight Sparkes: Canadian Glomerulonephritis Registry, Toronto, ON, Canada.
Philip Boll: Division of Nephrology, Department of Medicine, Trillium Health Partners, Mississauga, ON, Canada.
Arenn Jauhal: Division of Nephrology, Department of Medicine, University Health Network, University of Toronto, ON, Canada. ORCID
Rohan John: Department of Pathology, Toronto General Hospital, University Health Network, Toronto, ON, Canada.
Carmen Avila-Casado: Department of Pathology, Toronto General Hospital, University Health Network, Toronto, ON, Canada.
Heather N Reich: Division of Nephrology, Department of Medicine, University Health Network, University of Toronto, ON, Canada. ORCID
Background: Glomerulonephritis (GN) is a leading cause of kidney failure and accounts for 20% of incident cases of end-stage kidney disease (ESKD) in Canada annually. Reversal of kidney injury and prevention of progression to kidney failure is possible; however, limited knowledge of underlying disease mechanisms and lack of noninvasive biomarkers and therapeutic targets are major barriers to successful therapeutic intervention. Multicenter approaches that link longitudinal clinical and outcomes data with serial biologic specimen collection would help bridge this gap. Objective: To establish a national, patient-centered, multidimensional web-based clinical database and federated virtual biobank to conduct human-based molecular and clinical research in GN in Canada. Design: Multicenter, prospective observational registry, starting in 2019. Setting: Nine participating Canadian tertiary care centers. patients: Adult patients with a histopathologic pattern of injury consistent with IgA nephropathy, focal and segmental glomerulosclerosis, minimal change disease, membranous nephropathy, C3 glomerulopathy, and membranoproliferative GN recruited within 24 months of biopsy. Measurements: Initial visits include detailed clinical, histopathological, and laboratory data collection, blood, urine, and tonsil swab biospecimen collection, and a self-administered quality of life questionnaire. Follow-up clinical and laboratory data collection, biospecimen collection, and questionnaires are obtained every 6 months thereafter. Methods: patients receive care as defined by their physician, with study visits scheduled every 6 months. patients are followed until death, dialysis, transplantation, or withdrawal from the study. Key outcomes include a composite of ESKD or a 40% decline in estimated glomerular filtration rate (eGFR) at 2 years, rate of kidney function decline, and remission of proteinuria. Clinical and molecular phenotypical data will be analyzed by GN subtype to identify disease predictors and discover therapeutic targets. Limitations: Given the relative rarity of individual glomerular diseases, one of the major challenges is patient recruitment. Initial registry studies may be underpowered to detect small differences in clinically meaningful outcomes such as ESKD or death due to small sample sizes and short duration of follow-up in the initial 2-year phase of the study. Conclusions: The Canadian Glomerulonephritis Registry (CGNR) supports national collaborative efforts to study glomerular diseasepatients and their outcomes. Trial registration: NCT03460054.
