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The Canadian Glomerulonephritis Registry and Translational Research Initiative (CGNR)

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ClinicalTrials.gov Identifier: NCT03460054
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Sponsor:
Collaborators:
Sunnybrook Health Sciences Centre
Providence Health & Services
Foothills Medical Centre
McGill University Health Centre/Research Institute of the McGill University Health Centre
Queen Elizabeth II Health Sciences Centre
CHU de Quebec-Universite Laval
The Ottawa Hospital
University of Alberta
Information provided by (Responsible Party):
University Health Network, Toronto

Brief 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.

Condition or disease
Glomerular Nephritis

Detailed 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: The SPOR Canadian Glomerulonephritis Registry and Translational Research Initiative
Actual Study Start Date : October 19, 2017
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Group/Cohort
IgA Nephropathy (IgAN)
Biopsy-Proven IgAN
Focal Segmental Glomerulosclerosis (FSGS)
Biopsy-Proven FSGS
Membranous Nephropathy (MGN)
Biopsy-Proven MGN
Mesangioproliferative Glomerulonephritis (MPGN)
Biopsy-Proven MPGN
Minimal Change Disease (MCD)
Biopsy-Proven MCD



Primary Outcome Measures :
  1. Composite renal outcome (Estimated Glomerular Filtration Rate) [ Time Frame: 2 years ]
    End Stage Renal Disease (eGFR<15 or dialysis>60 days) or 40% decline in GFR at 2 years


Secondary Outcome Measures :
  1. Rate of renal function decline [ Time Frame: 2 years ]
    slope of least-squares regression line calculated for each person over 2 years

  2. Complete remission of proteinuria [ Time Frame: 2 years ]
    proteinuria <0.3g/day

  3. Partial remission of proteinuria [ Time Frame: 2 years ]
    Defined by % reduction in 24 hour protein excretion from peak value


Biospecimen Retention:   Samples With DNA
DNA, serum, plasma, urine and throat swabs will be obtained from patient at each research visit.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
- Adult patient who has biopsy proven IgAN or FSGS, MCD, MGN, MPGN with kidney function GFR>=30
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460054


Contacts
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Contact: Heather Reich, MD 416-340-3439 heather.reich@uhn.ca
Contact: Ping Lam, PhD 416-340-3514 ping.lam@uhn.ca

Locations
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Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G2C4
Contact: Ping Lam, PhD         
Sponsors and Collaborators
University Health Network, Toronto
Sunnybrook Health Sciences Centre
Providence Health & Services
Foothills Medical Centre
McGill University Health Centre/Research Institute of the McGill University Health Centre
Queen Elizabeth II Health Sciences Centre
CHU de Quebec-Universite Laval
The Ottawa Hospital
University of Alberta
Investigators
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Principal Investigator: Heather Reich, MD Nephrologist
Additional Information:

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03460054    
Other Study ID Numbers: CAPCR 16-6110
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nephritis
Glomerulonephritis
Kidney Diseases
Urologic Diseases