The Canadian Glomerulonephritis Registry and Translational Research Initiative

Glomerular Nephritis Clinical Trial

— CGNR  

Official title:

The SPOR Canadian Glomerulonephritis Registry and Translational Research Initiative

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03460054
• Other study ID #: CAPCR 16-6110
• Status: Recruiting
• Phase: N/A
• First received: February 16, 2018
• Last updated: March 2, 2018
• Start date: October 19, 2017
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2018
• Source: University Health Network, Toronto
• Contact: Heather Reich, MD
• Phone: 416-340-3439
• Email: heather.reich[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Glomerulonephritis (GN) is one of the most important causes of kidney failure in Canada. These comprise a group of "rare" diseases (<5 per 250,000 population), yet GN is a leading cause of kidney failure and accounts annually for close to 20% of incident cases of end stage kidney disease (ESKD) in Canada. Prevention of progression to kidney failure is possible, however several barriers and gaps in knowledge challenge our ability to provide patients with individualized effective therapy. These include a lack of sensitive non-invasive tools for monitoring disease activity, prognosis, and response to therapy. A gap in understanding of the core molecular processes underlying the development and progression of GN, and a lack of cohesive networks for evaluation of novel treatment approaches contribute to a lack of targeted and personalized therapies for GN. To address these challenges we will create a national, multi-dimensional platform for application of human-based molecular research and advanced therapeutics in GN.

Description:

To accomplish the goals set out in this project, the CGNR network will recruit and maintain a large cohort of patients 350 with glomerular diseases and follow them prospectively with standardized clinical data and biospecimen collection. The infrastructure and study design presented in this protocol will form the backbone for a broad range of scientific approaches and inquiries, essential to moving the field forward and improving the outcomes of patients affected by these diseases. Successful recruitment of 350 patients from across the country, creating a rich biobank and data repository. Our aims are to identifying patient characteristics associated with glomerular diseases and complications, characterizing disease trajectory under current clinical care, estimating event rates of clinically meaningful outcomes, identify predictors of short and long-term outcomes including therapeutic outcomes. We also aim to identify and characterize clinical, histological, molecular and genetic biomarkers that are linked to glomerular diseases and outcomes that might improve disease classification, and biomarkers that may be employed in clinical practice or in clinical trials that predict disease activity or response to therapy. Furthermore, we propose to study sequence variations, transcriptome profile and their impact on disease presentation and clinical outcome. On the patient level, we will identify patient reported outcomes such as disease burden, physical function and quality of life associated with GN diseases and validate tools to assess impact of disease and therapy on patients. Achievement of our goals will be determined by the success of the research studies that evolve from the biobank, and data repository.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• diagnosis of IgAN, FSGS, MCD, MGN, MPGN

• age 18-80 inclusive

• estimated GFR>=30ml/min/1.73m2 estimated using 4 variable MDRD

• first kidney biopsy within 12 months of enrollment

• connective tissue disease serology is normal/negative ANA, ANCA

Exclusion Criteria:

• Systemic lupus erythematosus (SLE) - serology supported

• Evidence of diabetic nephropathy on renal biopsy

• Underlying connective tissue disease and/or serologic evidence (sarcoid, rheumatoid arthritis, vasculitis)

• Prior organ transplant

Related Conditions & MeSH terms

• Glomerular Nephritis
• Glomerulonephritis
• Nephritis

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (9)

Lead Sponsor	Collaborator
University Health Network, Toronto	CHU de Quebec-Universite Laval, Foothills Medical Centre, McGill University Health Center, Providence Health & Services, QEII Health Sciences Centre, Sunnybrook Health Sciences Centre, The Ottawa Hospital, University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite renal outcome (Estimated Glomerular Filtration Rate)	End Stage Renal Disease (eGFR<15 or dialysis>60 days) or 40% decline in GFR at 2 years	2 years
Secondary	Rate of renal function decline	slope of least-squares regression line calculated for each person over 2 years	2 years
Secondary	Complete remission of proteinuria	proteinuria <0.3g/day	2 years
Secondary	Partial remission of proteinuria	Defined by % reduction in 24 hour protein excretion from peak value	2 years