NCT03460054

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 9, 2018

Status Verified

February 1, 2018

Enrollment Period

5.2 years

First QC Date

February 16, 2018

Last Update Submit

March 2, 2018

Conditions

Glomerular Nephritis

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Secondary Outcomes (3)

  • Rate of renal function decline

    2 years

  • Complete remission of proteinuria

    2 years

  • Partial remission of proteinuria

    2 years

Study Arms (5)

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\- Adult patient who has biopsy proven IgAN or FSGS, MCD, MGN, MPGN with kidney function GFR\>=30

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G2C4, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35450151DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA, serum, plasma, urine and throat swabs will be obtained from patient at each research visit.

MeSH Terms

Conditions

Glomerulonephritis

Condition Hierarchy (Ancestors)

NephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Heather Reich, MD

    Nephrologist

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Reich, MD

CONTACT

416-340-3439heather.reich@uhn.ca

Ping Lam, PhD

CONTACT

416-340-3514ping.lam@uhn.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2018

First Posted

March 9, 2018

Study Start

October 19, 2017

Primary Completion

December 30, 2022

Study Completion

June 30, 2023

Last Updated

March 9, 2018

Record last verified: 2018-02

Locations

CA(1)