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The Canadian Glomerulonephritis Registry and Translational Research Initiative (CGNR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date February 16, 2018
First Posted Date March 9, 2018
Last Update Posted Date March 9, 2018
Actual Study Start Date October 19, 2017
Estimated Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 2, 2018)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 2, 2018)
  • Rate of renal function decline [ Time Frame: 2 years ]
    slope of least-squares regression line calculated for each person over 2 years
  • Complete remission of proteinuria [ Time Frame: 2 years ]
    proteinuria <0.3g/day
  • Partial remission of proteinuria [ Time Frame: 2 years ]
    Defined by % reduction in 24 hour protein excretion from peak value
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Canadian Glomerulonephritis Registry and Translational Research Initiative
Official Title The SPOR Canadian Glomerulonephritis Registry and Translational Research Initiative
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.
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Retention:   Samples With DNA
Description:
DNA, serum, plasma, urine and throat swabs will be obtained from patient at each research visit.
Sampling Method Non-Probability Sample
Study Population - Adult patient who has biopsy proven IgAN or FSGS, MCD, MGN, MPGN with kidney function GFR>=30
Condition Glomerular Nephritis
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Hildebrand AM, Barua M, Barbour SJ, Tennankore KK, Cattran DC, Takano T, Lam P, De Serres SA, Samanta R, Hladunewich MA, Fairhead T, Poyah P, Bush DD, MacLaren B, Sparkes D, Boll P, Jauhal A, John R, Avila-Casado C, Reich HN. The Canadian Glomerulonephritis Registry (CGNR) and Translational Research Initiative: Rationale and Clinical Research Protocol. Can J Kidney Health Dis. 2022 Apr 8;9:20543581221089094. doi: 10.1177/20543581221089094. eCollection 2022.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 2, 2018)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2023
Estimated Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Heather Reich, MD 416-340-3439 heather.reich@uhn.ca
Contact: Ping Lam, PhD 416-340-3514 ping.lam@uhn.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03460054
Other Study ID Numbers CAPCR 16-6110
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party University Health Network, Toronto
Original Responsible Party Same as current
Current Study Sponsor University Health Network, Toronto
Original Study Sponsor Same as current
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
Investigators
Principal Investigator: Heather Reich, MD Nephrologist
PRS Account University Health Network, Toronto
Verification Date February 2018