The Canadian Glomerulonephritis Registry and Translational Research Initiative

NCT ID: NCT03460054

Last Updated: 2018-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-19

Study Completion Date

2023-06-30

Brief Summary

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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

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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.

Conditions

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Glomerular Nephritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IgA Nephropathy (IgAN)

Biopsy-Proven IgAN

No interventions assigned to this group

Focal Segmental Glomerulosclerosis (FSGS)

Biopsy-Proven FSGS

No interventions assigned to this group

Membranous Nephropathy (MGN)

Biopsy-Proven MGN

No interventions assigned to this group

Mesangioproliferative Glomerulonephritis (MPGN)

Biopsy-Proven MPGN

No interventions assigned to this group

Minimal Change Disease (MCD)

Biopsy-Proven MCD

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role collaborator

Providence Health & Services

OTHER

Sponsor Role collaborator

Foothills Medical Centre

OTHER

Sponsor Role collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role collaborator

Queen Elizabeth II Health Sciences Centre

OTHER

Sponsor Role collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role collaborator

The Ottawa Hospital

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heather Reich, MD

Role: PRINCIPAL_INVESTIGATOR

Nephrologist

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Heather Reich, MD

Role: CONTACT

416-340-3439

Ping Lam, PhD

Role: CONTACT

416-340-3514

Facility Contacts

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Ping Lam, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 35450151 (View on PubMed)

Other Identifiers

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CAPCR 16-6110

Identifier Type: -

Identifier Source: org_study_id

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