Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT03460054

Conditions

Glomerular Nephritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Glomerular Nephritis

Study ID

NCT03460054

Start date

Oct 19, 2017

Status verified date

Feb, 2018

Completion date

Jun 30, 2023

Anticipated

Primary completion date

Dec 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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 measure

  • Composite renal outcome (Estimated Glomerular Filtration Rate) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G2C4

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 9, 2018

Last verified

Feb, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2018-03-09.