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The Canadian Glomerulonephritis Registry (CGNR) and Translational Research Initiative: Rationale and Clinical
Ainslie M Hildebrand1, Moumita Barua2, Sean J Barbour3
1Division of Nephrology, Department of Medicine, University of Alberta, Edmonton, Canada.
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 disease patients and their outcomes.
Trial Registration:
NCT03460054.
Insights
The Canadian Glomerulonephritis Registry (CGNR) is a national database and biobank aiming to advance research into kidney diseases like IgA nephropathy. This initiative seeks to improve understanding and identify new treatments for glomerulonephritis (GN).
Area of Science:
- Nephrology and Kidney Diseases
- Immunopathology and Glomerular Injury
- Biomarker Discovery and Translational Research
Background:
- Glomerulonephritis (GN) is a significant cause of kidney failure, contributing to 20% of end-stage kidney disease (ESKD) cases in Canada.
- Limited understanding of disease mechanisms and lack of biomarkers hinder effective treatment for GN.
- A national, collaborative approach is needed to collect clinical and biological data for GN research.
Purpose of the Study:
- To establish a national, patient-centered clinical database and virtual biobank for GN research in Canada.
- To facilitate human-based molecular and clinical research to identify disease predictors and therapeutic targets.
Main Methods:
- A multicenter, prospective observational registry initiated in 2019 across nine Canadian tertiary care centers.
- Recruitment of adult patients with specific histopathological GN patterns within 24 months of biopsy.
- Collection of comprehensive clinical, histopathological, laboratory data, biospecimens (blood, urine, tonsil swabs), and quality of life questionnaires at baseline and every 6 months.
Main Results:
- The Canadian Glomerulonephritis Registry (CGNR) has been established, creating a national infrastructure for collaborative glomerular disease research.
- Longitudinal data and biospecimens are being collected to enable analysis of GN subtypes.
- The registry aims to identify disease predictors and potential therapeutic targets through clinical and molecular phenotyping.
Conclusions:
- The CGNR supports national collaborative efforts to study patients with glomerular diseases and their outcomes.
- This initiative is crucial for advancing the understanding and management of GN.
- Future analyses will focus on identifying key factors influencing kidney function decline and remission.
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