Glomerular NephritisCGNRNCT03460054
The Canadian Glomerulonephritis Registry and Translational Research Initiative
An observational study of Glomerular Nephritis, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glomerular Nephritis
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 19 Oct 2017to 30 Jun 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - Adult patient who has biopsy proven IgAN or FSGS, MCD, MGN, MPGN with kidney function GFR>=30
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G2C4
Ping Lam, PhD
About this study
Official title: The SPOR Canadian Glomerulonephritis Registry and Translational Research Initiative
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.
Read the 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.
- Conditions
- Glomerular Nephritis
- Medical subject headings
- Glomerulonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (3)
Rate of renal function decline
slope of least-squares regression line calculated for each person over 2 years
Measured: 2 years
Complete remission of proteinuria
proteinuria <0.3g/day
Measured: 2 years
Partial remission of proteinuria
Defined by % reduction in 24 hour protein excretion from peak value
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start19 Oct 2017
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glomerular NephritisStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Heather Reich, MD, Principal investigator, Nephrologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460054
- Sponsor's protocol ID
- CAPCR 16-6110
- Acronym
- CGNR
- Status last verified
- Feb 2018
- First submitted
- 16 Feb 2018
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35450151
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SPOR Canadian Glomerulonephritis Registry and Translational Research Initiative
- ClinicalTrials.gov ID
- NCT03460054
- Acronym / sponsor ID
- CGNR / CAPCR 16-6110
- Conditions
- Glomerular Nephritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- 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
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Adult patient who has biopsy proven IgAN or FSGS, MCD, MGN, MPGN with kidney function GFR>=30
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Rate of renal function decline
Time frame: 2 years
Complete remission of proteinuria
Time frame: 2 years
Partial remission of proteinuria
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Derived from this study: PubMed 35450151Hildebrand 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.
- Individual participant dataSharing planned: Undecided
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MYTP01 for Immune-Mediated Diseases
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Reich, MD principal investigator
Nephrologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glomerular Nephritis, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heather Reich, MD (416-340-3439, heather.reich@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite renal outcome (Estimated Glomerular Filtration Rate) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03460054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.